Hydrocortisone

Crown Laboratories
Human Prescription Drug
NDC 0316-0193

Hydrocortisone is a human prescription drug labeled by 'Crown Laboratories'. National Drug Code (NDC) number for Hydrocortisone is 0316-0193. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hydrocortisone drug includes Hydrocortisone - 25 mg/g . The currest status of Hydrocortisone drug is Active.

Drug Information:

Drug NDC:	0316-0193
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Hydrocortisone
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Hydrocortisone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Crown Laboratories
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	HYDROCORTISONE - 25 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	06 Jan, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA080706
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Crown Laboratories
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	106258 310891
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0303160193309 0303160186011
UPC stands for Universal Product Code.
NUI:	N0000175576 N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	WI4X0X7BPJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Corticosteroid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0316-0193-16	1 JAR in 1 CARTON (0316-0193-16) / 454 g in 1 JAR	06 Jan, 2016	N/A	No
0316-0193-20	1 TUBE in 1 CARTON (0316-0193-20) / 20 g in 1 TUBE	06 Jan, 2016	N/A	No
0316-0193-30	1 TUBE in 1 CARTON (0316-0193-30) / 30 g in 1 TUBE	06 Jan, 2016	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Cortef

Hydrocortisone

Tablet
Pharmacia & Upjohn Company LLC
NDC: 0009-0044

Product Elements:

Hydrocortisone hydrocortisone water cetyl alcohol stearyl alcohol glycerin propylene glycol sodium lauryl sulfate cetyl palmitate sorbic acid hydrocortisone hydrocortisone hydrocortisone hydrocortisone water cetyl alcohol stearyl alcohol glycerin propylene glycol sodium lauryl sulfate cetyl palmitate sorbic acid hydrocortisone hydrocortisone

Indications and Usage:

Indications and usage topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

General Precautions:

Precautions general systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushingâs syndrome, hyperglycemia, and glucosuria in some patients. conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of hpa axis suppression by using the urinary free cortisol and acth stimulation tests. if hpa axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. recovery of hpa axis function is generally prompt and complete upon discontinuation of the drug. infrequently, signs and symptoms of steroid withdrawa Read more...

l may occur, requiring supplemental systemic corticosteroids. pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see precautions-pediatric use ). if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. if a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Dosage and Administration:

Dosage and administration topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications:

Contraindications topcial corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions:

Adverse reactions the following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. these reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. to report suspected adverse reactions, contact crown laboratories, inc. at 1-423-926-4413 or fda at 1-800-fda-1088 or https://www.fda.gov/safety/medwatch/

Use in Pregnancy:

Pregnancy: teratogenic effects - pregnancy category c corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Pediatric Use:

Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushingâs syndrome than mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenai (hpa) axis suppression, cushingâs syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Overdosage:

Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systems effects (see precautions ).

Description:

Description the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. hydrocortisone is a member of this class. chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11Î²)-. its molecular formula is c 21 h 30 o 5 and molecular weight is 362.47. its structural formula is: each gram of hydrocortisone cream usp, 1% contains 10 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. each gram of hydrocortisone cream usp, 2.5% contains 25 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. hcstructure

Clinical Pharmacology:

Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics:

Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (see dosage and administration ). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the Read more...

bile.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

How Supplied:

How supplied hydrocortisone cream usp, 1% is supplied in: 1 ounce (28.4 grams) tube ndc 0316-0186-01 454 grams jar ndc 0316-0186-16 hydrocortisone cream usp, 2.5% is supplied in: 20 grams tube ndc 0316-0193-20 30 grams tube ndc 0316-0193-30 454 grams jar ndc 0316-0193-16 manufactured and distributed by: crown laboratories, inc., johnson city, tennessee 37604 printed in usa ârevised dec 2017 p6306.03

Information for Patients:

Information for the patient patients using topical corticosteroids should receive the following information and instructions: 1. this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. 2. patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. the treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. patients should report any signs of local adverse reactions especially under occlusive dressing. 5. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Package Label Principal Display Panel:

Hydrocortisone cream usp, 1% - 1oz label ndc 0316-0186-01 rx only hydrocortisone cream usp, 1% warning: keep out of reach of children. for external use only. not for ophthalmic use. 1oz (28.4 grams) each gram contains: 10 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. usual dosage: 2 to 4 applications daily. see package insert for full prescribing information. to open: use cap to pucture seal. important: do not use if seal has been puctured or is not visible. store at 20 o -25 o c (68 o -77 o f)[see usp controlled room temperature]. see crimp of tube for lot number and expiration date. manufactured and distributed by: crown laboratories, inc., johnson city, tn 37604 p6300.01 hc1% 1oz tube

Hydrocortisone cream usp, 1% -1oz carton ndc 0316-0186-01 rx only hydrocortisone cream usp, 1% warning: keep out of reach of children. for external use only. not for ophthalmic use. 1oz (28.4 grams) each gram contains: 10 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. directions for puncturing tube seal: remove cap. turn cap upside down and place puncture tip onto tube seal. push cap down until seal is punctured. screw cap back on to reseal tube. store at 20 o -25 o c (68 o -77 o f)[see usp controlled room temperature]. usual dosage: 2 to 4 applications daily. see package insert for full prescribing information. see end of carton for lot number and expiration date. manufactured and distributed by: crown laboratories, inc., johnson city, tn 37604 p6304.02 hc1%-1oz-carton

Hydrocortisone cream usp, 2.5% 30 grams label ndc 0316-0193-30 rx only hydrocortisone cream usp, 2.5% 30 grams warning: keep out of reach of children. for external use only. not for ophthalmic use. each gram contains: 25 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. usual dosage: 2 to 4 applications daily. see package insert for full prescribing information. to open: use cap to puncture seal. important: do not use if seal has been punctured or is not visible. store at 20Â°c-25Â°c (68Â°-77Â°f) [see usp controlled room temperature]. see crimp of tube for lot number and expiration date. manufactured and distributed by: crown laboratories, inc., johnson city, tn 37604 p11337.00 hc 2.5% 30g tube

Hydrocortisone cream usp, 2.5% 30 grams carton ndc 0316-0193-30 rx only hydrocortisone cream usp, 2.5% warning: keep out of reach of children. for external use only. not for ophthalmic use. 30 grams each gram contains: 25 mg hydrocortisone usp in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. usual dosage: 2 to 4 applications daily. see package insert for full prescribing information. directions for puncturing tube seal: remove cap. turn cap upside down and place puncture tip onto tube seal. push cap down until seal is punctured. screw cap back on to reseal tube. important: do not use if seal has been punctured or is not visible. store at 20Â°-25Â°c (68Â°-77Â°f) [see usp controlled room temperature]. see end of carton for lot number and expiration date. manufactured and distributed by: crown laboratories, inc., johnson city, tn 37604 p11338.00 hc 2.5% 30g carton

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