diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-611
Product ID 68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218448
Listing Expiration 2026-12-31
Marketing Start 2024-03-20

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 68083611
Hyphenated Format 68083-611

Supplemental Identifiers

RxCUI
1723740
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 ANDA218448 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIAL
source: ndc

Packages (1)

68083-611-25 25 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIAL

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": "89f09a33-2535-47c9-8942-dd8ebe5d3b4a", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["eeb70724-065c-4a73-8e2e-d6b2a625e8d4"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-611-25)  / 1 mL in 1 VIAL", "package_ndc": "68083-611-25", "marketing_start_date": "20240320"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4a", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68083-611", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA218448", "marketing_category": "ANDA", "marketing_start_date": "20240320", "listing_expiration_date": "20261231"}