famotidine

Generic: famotidine

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

famotidine 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1375
Product ID 51662-1375_e9fd11b6-5cbd-ba83-e053-2a95a90a42af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075813
Listing Expiration 2026-12-31
Marketing Start 2019-12-09

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 516621375
Hyphenated Format 51662-1375

Supplemental Identifiers

RxCUI
1743833
UPC
0363323739119
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

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 ANDA075813 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1)
  • 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1375-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1) 51662-1375-2 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2) / 2 mL in 1 VIAL, SINGLE-DOSE

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": "e9fd11b6-5cbd-ba83-e053-2a95a90a42af", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0363323739119"], "unii": ["5QZO15J2Z8"], "rxcui": ["1743833"], "spl_set_id": ["9948991d-9405-c7c8-e053-2995a90a60ca"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1)", "package_ndc": "51662-1375-1", "marketing_start_date": "20191209"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1375-2", "marketing_start_date": "20221001"}], "brand_name": "FAMOTIDINE", "product_id": "51662-1375_e9fd11b6-5cbd-ba83-e053-2a95a90a42af", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "51662-1375", "generic_name": "FAMOTIDINE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FAMOTIDINE", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/mL"}], "application_number": "ANDA075813", "marketing_category": "ANDA", "marketing_start_date": "20191209", "listing_expiration_date": "20261231"}