diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler cardinal health 107, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-9363
Product ID 55154-9363_7bf6446b-a127-4c1a-b601-857d786025dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040466
Listing Expiration 2026-12-31
Marketing Start 2002-08-01

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 551549363
Hyphenated Format 55154-9363

Supplemental Identifiers

RxCUI
1723740
UPC
0055154936354
UNII
TC2D6JAD40

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 ANDA040466 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 BAG (55154-9363-5) / 1 mL in 1 VIAL
source: ndc

Packages (1)

55154-9363-5 5 VIAL in 1 BAG (55154-9363-5) / 1 mL in 1 VIAL

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": "7bf6446b-a127-4c1a-b601-857d786025dd", "openfda": {"upc": ["0055154936354"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["50df93bf-fe72-48f6-a02e-ea9a313d47c2"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 BAG (55154-9363-5)  / 1 mL in 1 VIAL", "package_ndc": "55154-9363-5", "marketing_start_date": "20020801"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "55154-9363_7bf6446b-a127-4c1a-b601-857d786025dd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55154-9363", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA040466", "marketing_category": "ANDA", "marketing_start_date": "20020801", "listing_expiration_date": "20261231"}