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 63323-664
Product ID 63323-664_38e8f892-3aa1-473f-9906-8b7ee5d23e89
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 63323664
Hyphenated Format 63323-664

Supplemental Identifiers

RxCUI
1723740
UPC
0363323664411
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 in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)
source: ndc

Packages (1)

63323-664-16 25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/mL)

Linked Drug Pages (2)

Diphenhydramine ndc-match (0.9) Diphenhydramine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "38e8f892-3aa1-473f-9906-8b7ee5d23e89", "openfda": {"upc": ["0363323664411"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["921b9f64-1096-46db-866a-67f0f9ff6790"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-664-16)  / 1 mL in 1 VIAL (63323-664-41)", "package_ndc": "63323-664-16", "marketing_start_date": "20020801"}], "brand_name": "Diphenhydramine", "product_id": "63323-664_38e8f892-3aa1-473f-9906-8b7ee5d23e89", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63323-664", "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": "20020801", "listing_expiration_date": "20261231"}