diphenhydramine

Generic: diphenhydramine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine
Generic Name diphenhydramine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-820
Product ID 65219-820_f4f0c26b-dad0-47a1-a9e7-6558c11254c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040466
Listing Expiration 2026-12-31
Marketing Start 2025-05-05

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 65219820
Hyphenated Format 65219-820

Supplemental Identifiers

RxCUI
1723740
UPC
0365219820000
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 (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
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-820-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-820-00)
source: ndc

Packages (1)

65219-820-01 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-820-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-820-00)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Diphenhydramine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "f4f0c26b-dad0-47a1-a9e7-6558c11254c0", "openfda": {"upc": ["0365219820000"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["f4f0c26b-dad0-47a1-a9e7-6558c11254c0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-820-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (65219-820-00)", "package_ndc": "65219-820-01", "marketing_start_date": "20250505"}], "brand_name": "Diphenhydramine", "product_id": "65219-820_f4f0c26b-dad0-47a1-a9e7-6558c11254c0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65219-820", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA040466", "marketing_category": "ANDA", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}