diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-263
Product ID 23155-263_8f3f83d2-d97e-4f82-b3e5-f8840fa6b443
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205337
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

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 23155263
Hyphenated Format 23155-263

Supplemental Identifiers

RxCUI
1049633
UPC
0323155263312
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 ANDA205337 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 PACKAGE (23155-263-31) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

23155-263-31 1 VIAL, GLASS in 1 PACKAGE (23155-263-31) / 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": "8f3f83d2-d97e-4f82-b3e5-f8840fa6b443", "openfda": {"upc": ["0323155263312"], "unii": ["TC2D6JAD40"], "rxcui": ["1049633"], "spl_set_id": ["6178d3a1-0741-49a4-be81-c4f7d29f8b2a"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 PACKAGE (23155-263-31)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "23155-263-31", "marketing_start_date": "20251215"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "23155-263_8f3f83d2-d97e-4f82-b3e5-f8840fa6b443", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "23155-263", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA205337", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}