famotidine

Generic: famotidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-533
Product ID 43063-533_41392bae-3ede-5191-e063-6294a90ac386
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075511
Listing Expiration 2026-12-31
Marketing Start 2001-04-16

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 43063533
Hyphenated Format 43063-533

Supplemental Identifiers

RxCUI
284245
UPC
0343063533307
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 ANDA075511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-533-30)
source: ndc

Packages (1)

43063-533-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-533-30)

Ingredients (1)

famotidine (40 mg/1)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41392bae-3ede-5191-e063-6294a90ac386", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0343063533307"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["5798d282-ce83-49aa-bc33-13203f2b5285"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-533-30)", "package_ndc": "43063-533-30", "marketing_start_date": "20140414"}], "brand_name": "Famotidine", "product_id": "43063-533_41392bae-3ede-5191-e063-6294a90ac386", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "43063-533", "generic_name": "Famotidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA075511", "marketing_category": "ANDA", "marketing_start_date": "20010416", "listing_expiration_date": "20261231"}