Diphenhydramine Hydrochloride
Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9851Diphenhydramine Hydrochloride is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Diphenhydramine Hydrochloride is 0404-9851. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Diphenhydramine Hydrochloride drug includes Diphenhydramine Hydrochloride - 50 mg/mL . The currest status of Diphenhydramine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 0404-9851 |
| 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: | Diphenhydramine Hydrochloride |
| 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: | Diphenhydramine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Henry Schein, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 50 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
|
| 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: | 17 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | ANDA080817 |
| 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: | Henry Schein, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1723740
|
| 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. |
| UNII: | TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 0404-9851-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9851-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 17 Jan, 2022 | 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. |
Product Elements:
Diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine benzethonium chloride water sodium hydroxide hydrochloric acid
Indications and Usage:
Indications and usage diphenhydramine hydrochloride injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical: antihistaminic- for amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. motion sickness- for active treatment of motion sickness. antiparkinsonism- for use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases at parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
Warnings:
Warnings antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction. local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine. use in pediatric patients in pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions or death. as in adults, antihistamines may diminish mental alertness in pediatric patients. in the young pediatric patient, particularly, they may produce excitation. use in the elderly (approximately 60 years or older) antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
Dosage and Administration:
Dosage and administration this product is for intravenous or intramuscular administration only. diphenhydramine hydrochloride injection is indicated when the oral form is impractical. dosage should be individualized according to the needs and the response of the patient pediatric patients, other than premature infants and neonates 5 mg/kg/24 hours or 150 mg/m/24 hours. maximum daily dosage is 300 mg. divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly. adults 10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications use in neonates or premature infants this drug should not be used in neonates or premature infants. use in nursing mothers because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. use as a local anesthetic because of the risk of local necrosis, this drug should not be used as a local anesthetic. antihistamines are also contraindicated in the following conditions hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
Adverse Reactions:
Adverse reactions the most frequent adverse reactions are italicized. general urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. cardiovascular system hypotension, headache, palpitations, tachycardia, extrasystoles. hematologic system hemolytic anemia, thrombocytopenia, agranulocytosis. nervous system sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. gastrointestinal system epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. genitourinary system urinary frequency, difficult urination, urinary retention, early menses. respiratory system thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.
Overdosage:
Overdosage antihistamine overdosage reactions may vary from central nervous system depression to stimulation. stimulation is particularly likely in pediatric patients. atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur. stimulants should not be used. vasopressors may be used to treat hypotension.
Description:
Description diphenhydramine hydrochloride injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. each ml contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in water for injection. ph 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for ph adjustment. the chemical name of diphenhydramine hydrochloride is 2-(diphenylmethoxy) -n,n- dimethylethylamine hydrochloride. the structural formula is as follows: c17h21no ⢠hcl mw 291.82 diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol. formula1
Clinical Pharmacology:
Clinical pharmacology diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. antihistamines appear to compete with histamine for cell receptor sites on effector cells. diphenhydramine hydrochloride in the injectable form has a rapid onset of action. diphenhydramine is widely distributed throughout the body, including the cns. a portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. detailed information on the pharmacokinetics of diphenhydramine hydrochloride injection is not available.
How Supplied:
How supplied diphenhydramine hydrochloride injection, usp 50 mg/ml 1 ml vials packaged in 25s (ndc 0641-0376-25) product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 0641-0376-25 1 ml vials packaged in 25s ndc 0404-9851-01 1 vial in a bag (vial bears ndc 0641-0376-21) 50mg/ml storage protect from light. keep covered in carton until time of use. store at 20°-25°c (68°-77°f), excursions permitted to 15°-30°c (59°-86°f) [see usp controlled room temperature]. to report suspected adverse reactions, contact hikma pharmaceuticals usa inc. at 1-877-845-0689, or the fda at 1-800-fda-1088 or www.fda.gov/medwatch. for product inquiry call 1-877-845-0689. manufactured by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 revised december 2019 462-220-02
Package Label Principal Display Panel:
Sample package label label1.jpg