Diphenhydramine Hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: Mylan Institutional LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Diphenhydramine Hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler Mylan Institutional LLC
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL

Identifiers & Regulatory

Product NDC 67457-124
Product ID 67457-124_c12e82a6-43b8-4318-8fe1-4c06ba191077
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040498
Marketing Start 2013-05-09
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457124
Hyphenated Format 67457-124

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 ANDA040498 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (67457-124-10) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67457-124-10 1 VIAL, GLASS in 1 CARTON (67457-124-10) / 10 mL in 1 VIAL, 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": "c12e82a6-43b8-4318-8fe1-4c06ba191077", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049633"], "spl_set_id": ["82cd7a3c-acd6-44dc-8c95-f066162a510c"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (67457-124-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "67457-124-10", "marketing_end_date": "20260228", "marketing_start_date": "20130509"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "67457-124_c12e82a6-43b8-4318-8fe1-4c06ba191077", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "67457-124", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA040498", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20130509"}