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 23155-264
Product ID 23155-264_94dd89a8-b3cd-45cf-abdd-ff383e3a24d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205336
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

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 23155264
Hyphenated Format 23155-264

Supplemental Identifiers

RxCUI
1723740
UPC
0323155264319
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 ANDA205336 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 PACKAGE (23155-264-41) / 1 mL in 1 VIAL, GLASS (23155-264-31)
source: ndc

Packages (1)

23155-264-41 25 VIAL, GLASS in 1 PACKAGE (23155-264-41) / 1 mL in 1 VIAL, GLASS (23155-264-31)

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": "94dd89a8-b3cd-45cf-abdd-ff383e3a24d9", "openfda": {"upc": ["0323155264319"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["483fbd4c-25c7-4553-8c3f-089daca84ae6"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 PACKAGE (23155-264-41)  / 1 mL in 1 VIAL, GLASS (23155-264-31)", "package_ndc": "23155-264-41", "marketing_start_date": "20250630"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "23155-264_94dd89a8-b3cd-45cf-abdd-ff383e3a24d9", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "23155-264", "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": "ANDA205336", "marketing_category": "ANDA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}