diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
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 76045-102
Product ID 76045-102_5bfd2f08-2d90-47b1-9677-73c503e66956
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091526
Listing Expiration 2026-12-31
Marketing Start 2013-03-26

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 76045102
Hyphenated Format 76045-102

Supplemental Identifiers

RxCUI
1049289
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 ANDA091526 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-102-10 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00) / 1 mL in 1 SYRINGE, GLASS

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": "5bfd2f08-2d90-47b1-9677-73c503e66956", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049289"], "spl_set_id": ["6d1aa0e2-036d-4382-a458-fc0300dba7cb"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-102-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-102-10", "marketing_start_date": "20130326"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "76045-102_5bfd2f08-2d90-47b1-9677-73c503e66956", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76045-102", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA091526", "marketing_category": "ANDA", "marketing_start_date": "20130326", "listing_expiration_date": "20261231"}