diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-481
Product ID 25021-481_7521506e-027f-48b1-bd2d-66ad01f01c82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218448
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

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 25021481
Hyphenated Format 25021-481

Supplemental Identifiers

RxCUI
1723740
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 ANDA218448 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (25021-481-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

25021-481-01 25 VIAL in 1 CARTON (25021-481-01) / 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": "7521506e-027f-48b1-bd2d-66ad01f01c82", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["6533e629-a27b-4489-8fa3-7de32fbf809e"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (25021-481-01)  / 1 mL in 1 VIAL", "package_ndc": "25021-481-01", "marketing_start_date": "20250115"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "25021-481_7521506e-027f-48b1-bd2d-66ad01f01c82", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "25021-481", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA218448", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}