diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0376
Product ID 0641-0376_a26a0df5-fdb8-4c50-ac01-8ae033578bf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080817
Listing Expiration 2026-12-31
Marketing Start 1972-11-27

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06410376
Hyphenated Format 0641-0376

Supplemental Identifiers

RxCUI
1049633
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number ANDA080817 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 PACKAGE (0641-0376-25) / 1 mL in 1 VIAL (0641-0376-21)
source: ndc

Packages (1)

0641-0376-25 25 VIAL in 1 PACKAGE (0641-0376-25) / 1 mL in 1 VIAL (0641-0376-21)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "a26a0df5-fdb8-4c50-ac01-8ae033578bf0", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049633"], "spl_set_id": ["ec691492-a295-4b48-a1a3-5824931efa97"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 PACKAGE (0641-0376-25)  / 1 mL in 1 VIAL (0641-0376-21)", "package_ndc": "0641-0376-25", "marketing_start_date": "19721127"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "0641-0376_a26a0df5-fdb8-4c50-ac01-8ae033578bf0", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0641-0376", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA080817", "marketing_category": "ANDA", "marketing_start_date": "19721127", "listing_expiration_date": "20261231"}