diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler micro labs limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-511
Product ID 42571-511_3d083da4-429e-73c5-e063-6394a90ad2c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219845
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

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 42571511
Hyphenated Format 42571-511

Supplemental Identifiers

RxCUI
1049633
UPC
0342571511562
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 ANDA219845 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (42571-511-56) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

42571-511-56 1 VIAL, GLASS in 1 CARTON (42571-511-56) / 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": "3d083da4-429e-73c5-e063-6394a90ad2c1", "openfda": {"upc": ["0342571511562"], "unii": ["TC2D6JAD40"], "rxcui": ["1049633"], "spl_set_id": ["c2981222-1671-4ecd-a5a2-286f0663f1ae"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (42571-511-56)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "42571-511-56", "marketing_start_date": "20251101"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "42571-511_3d083da4-429e-73c5-e063-6394a90ad2c1", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42571-511", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA219845", "marketing_category": "ANDA", "marketing_start_date": "20251101", "listing_expiration_date": "20261231"}