Hydrocortisone And Acetic Acid

Akorn Operating Company Llc
Human Prescription Drug
NDC 50383-901

Hydrocortisone And Acetic Acid is a human prescription drug labeled by 'Akorn Operating Company Llc'. National Drug Code (NDC) number for Hydrocortisone And Acetic Acid is 50383-901. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Hydrocortisone And Acetic Acid drug includes Acetic Acid - 20.75 mg/mL Hydrocortisone - 10.375 mg/mL . The currest status of Hydrocortisone And Acetic Acid drug is Active.

Drug Information:

Drug NDC:	50383-901
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 And Acetic Acid
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 And Acetic Acid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Akorn Operating Company Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
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:	ACETIC ACID - 20.75 mg/mL HYDROCORTISONE - 10.375 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	AURICULAR (OTIC)
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:	NDA
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:	04 Jun, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 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:	NDA012770
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, 2023
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:	Akorn Operating Company LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	313786
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.
NUI:	N0000175576 N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	Q40Q9N063P 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
50383-901-10	1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) / 10 mL in 1 BOTTLE, DROPPER	04 Jun, 2009	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

Hydrocortisone And Acetic Acid

Solution
Taro Pharmaceuticals U.S.A., Inc.
NDC: 51672-3007

Hydrocortisone And Acetic Acid

Solution
Akorn Operating Company LLC
NDC: 50383-901

Product Elements:

Hydrocortisone and acetic acid hydrocortisone and acetic acid acetic acid acetic acid hydrocortisone hydrocortisone anhydrous citric acid benzethonium chloride propylene glycol propylene glycol diacetate sodium acetate

Indications and Usage:

Indications and usage for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

Warnings:

Warnings discontinue promptly if sensitization or irritation occurs.

Dosage and Administration:

Dosage and administration carefully remove all cerumen and debris to allow hydrocortisone and acetic acid to contact infected surfaces directly. to promote continuous contact, insert a wick of cotton saturated with hydrocortisone and acetic acid into the ear canal; the wick may also be saturated after insertion. instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of hydrocortisone and acetic acid every 4 to 6 hours. the wick may be removed after 24 hours but the patient should continue to instill 5 drops of hydrocortisone and acetic acid 3 or 4 times daily thereafter, for as long as indicated. in pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

Contraindications:

Contraindications hypersensitivity to hydrocortisone and acetic acid or any of the ingredients; herpes simplex, vaccinia and varicella. perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Adverse Reactions:

Adverse reactions stinging or burning may be noted occasionally; local irritation has occurred very rarely.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Description:

Description hydrocortisone and acetic acid otic solution, usp is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). the empirical formulas for acetic acid and hydrocortisone are ch 3 cooh, and c 21 h 30 o 5 , with a molecular weight of 60.05 and 362.46, respectively. the structural formulas are: hydrocortisone and acetic acid is available as a nonaqueous otic solution buffered at ph 3 for use in the external ear canal. chemical structuracetic acid chemical structure_hydrocortisone

Clinical Pharmacology:

Clinical pharmacology acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

How Supplied:

How supplied hydrocortisone and acetic acid otic solution, usp, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 ml, measured-drop, safety-tip plastic bottles (ndc 50383-901-10).

Package Label Principal Display Panel:

Package/label principal display panel akorn ndc 50383-901-10 hydrocortisone and acetic acid otic solution, usp 10 ml rx only carton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.