famotidine

Generic: famotidine

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

famotidine 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-448
Product ID 67457-448_04ba0afe-908e-4948-a757-44b59de09ae3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078641
Listing Expiration 2026-12-31
Marketing Start 2008-06-26

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457448
Hyphenated Format 67457-448

Supplemental Identifiers

RxCUI
204441 1743833
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA078641 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00)
source: ndc

Packages (1)

67457-448-43 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00)

Ingredients (1)

famotidine (10 mg/mL)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "04ba0afe-908e-4948-a757-44b59de09ae3", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["204441", "1743833"], "spl_set_id": ["e3b13e23-122b-4bd4-95cf-b5a14b7afc05"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (67457-448-43)  / 4 mL in 1 VIAL (67457-448-00)", "package_ndc": "67457-448-43", "marketing_start_date": "20080626"}], "brand_name": "Famotidine", "product_id": "67457-448_04ba0afe-908e-4948-a757-44b59de09ae3", "dosage_form": "INJECTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "67457-448", "generic_name": "Famotidine", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/mL"}], "application_number": "ANDA078641", "marketing_category": "ANDA", "marketing_start_date": "20080626", "listing_expiration_date": "20261231"}