diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: armas pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler armas pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-101
Product ID 72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205723
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 72485101
Hyphenated Format 72485-101

Supplemental Identifiers

RxCUI
1723740
UPC
0372485101016
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 ANDA205723 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)
source: ndc

Packages (2)

72485-101-05 5 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01) 72485-101-25 25 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)

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": "d949ac61-1864-4cf8-9b51-738b29952cc2", "openfda": {"upc": ["0372485101016"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05)  / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)", "package_ndc": "72485-101-05", "marketing_start_date": "20230505"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)", "package_ndc": "72485-101-25", "marketing_start_date": "20190501"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72485-101", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA205723", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}