famotidine

Generic: famotidine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-535
Product ID 71205-535_37ca9d4f-3fed-421a-a18f-a9954c00a90c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206530
Listing Expiration 2026-12-31
Marketing Start 2015-12-22

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 71205535
Hyphenated Format 71205-535

Supplemental Identifiers

RxCUI
310273
UPC
0371205535308
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 ANDA206530 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE (71205-535-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71205-535-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-535-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-535-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71205-535-78)
source: ndc

Packages (5)

71205-535-06 6 TABLET, FILM COATED in 1 BOTTLE (71205-535-06) 71205-535-10 10 TABLET, FILM COATED in 1 BOTTLE (71205-535-10) 71205-535-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-535-30) 71205-535-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-535-60) 71205-535-78 180 TABLET, FILM COATED in 1 BOTTLE (71205-535-78)

Ingredients (1)

famotidine (20 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": "37ca9d4f-3fed-421a-a18f-a9954c00a90c", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0371205535308"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["4adb4864-04ac-4cb1-96c2-6196a30ac640"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (71205-535-06)", "package_ndc": "71205-535-06", "marketing_start_date": "20210224"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71205-535-10)", "package_ndc": "71205-535-10", "marketing_start_date": "20210224"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-535-30)", "package_ndc": "71205-535-30", "marketing_start_date": "20210216"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-535-60)", "package_ndc": "71205-535-60", "marketing_start_date": "20210216"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71205-535-78)", "package_ndc": "71205-535-78", "marketing_start_date": "20240906"}], "brand_name": "Famotidine", "product_id": "71205-535_37ca9d4f-3fed-421a-a18f-a9954c00a90c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "71205-535", "generic_name": "Famotidine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA206530", "marketing_category": "ANDA", "marketing_start_date": "20151222", "listing_expiration_date": "20261231"}