famotidine

Generic: famotidine

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

famotidine 20 mg/50mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-5197
Product ID 0338-5197_19d9e59f-3373-4237-b252-d3d6ba9e58cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075591
Listing Expiration 2026-12-31
Marketing Start 2001-05-10

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 03385197
Hyphenated Format 0338-5197

Supplemental Identifiers

RxCUI
199739
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 ANDA075591 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/50mL
source: ndc
Packaging
  • 12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG
source: ndc

Packages (1)

0338-5197-41 12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG

Ingredients (1)

famotidine (20 mg/50mL)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "19d9e59f-3373-4237-b252-d3d6ba9e58cd", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199739"], "spl_set_id": ["97c33213-f415-4718-8466-9aa50371af70"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (0338-5197-41)  / 50 mL in 1 BAG", "package_ndc": "0338-5197-41", "marketing_start_date": "20010510"}], "brand_name": "Famotidine", "product_id": "0338-5197_19d9e59f-3373-4237-b252-d3d6ba9e58cd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0338-5197", "generic_name": "Famotidine", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/50mL"}], "application_number": "ANDA075591", "marketing_category": "ANDA", "marketing_start_date": "20010510", "listing_expiration_date": "20261231"}