diphenhydramine

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 50 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-337
Product ID 42571-337_4c46492b-00c4-8ee4-e063-6294a90a6914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205723
Listing Expiration 2027-12-31
Marketing Start 2019-12-10

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 42571337
Hyphenated Format 42571-337

Supplemental Identifiers

RxCUI
1723740
UPC
0342571337957 0342571169541
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 (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
  • 1 VIAL in 1 CARTON (42571-337-56) / 1 mL in 1 VIAL
  • 5 VIAL in 1 CARTON (42571-337-78) / 1 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (42571-337-87) / 1 mL in 1 VIAL (42571-337-95)
source: ndc

Packages (3)

42571-337-56 1 VIAL in 1 CARTON (42571-337-56) / 1 mL in 1 VIAL 42571-337-78 5 VIAL in 1 CARTON (42571-337-78) / 1 mL in 1 VIAL 42571-337-87 25 VIAL in 1 CARTON (42571-337-87) / 1 mL in 1 VIAL (42571-337-95)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

DIPHENHYDRAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "4c46492b-00c4-8ee4-e063-6294a90a6914", "openfda": {"upc": ["0342571337957", "0342571169541"], "unii": ["TC2D6JAD40"], "rxcui": ["1723740"], "spl_set_id": ["a1110433-498a-48cb-ac79-5732fd4f8fba"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42571-337-56)  / 1 mL in 1 VIAL", "package_ndc": "42571-337-56", "marketing_start_date": "20260305"}, {"sample": false, "description": "5 VIAL in 1 CARTON (42571-337-78)  / 1 mL in 1 VIAL", "package_ndc": "42571-337-78", "marketing_start_date": "20260303"}, {"sample": false, "description": "25 VIAL in 1 CARTON (42571-337-87)  / 1 mL in 1 VIAL (42571-337-95)", "package_ndc": "42571-337-87", "marketing_start_date": "20191210"}], "brand_name": "DIPHENHYDRAMINE", "product_id": "42571-337_4c46492b-00c4-8ee4-e063-6294a90a6914", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42571-337", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIPHENHYDRAMINE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA205723", "marketing_category": "ANDA", "marketing_start_date": "20191210", "listing_expiration_date": "20271231"}