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
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-695
Product ID 43063-695_41478927-2719-0a32-e063-6294a90acdc9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075805
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 43063695
Hyphenated Format 43063-695

Supplemental Identifiers

RxCUI
310273
UPC
0343063695906
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 ANDA075805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-695-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-695-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-695-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-695-90)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43063-695-93)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43063-695-95)
source: ndc

Packages (6)

43063-695-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-695-20) 43063-695-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-695-30) 43063-695-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-695-60) 43063-695-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-695-90) 43063-695-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-695-93) 43063-695-95 1000 TABLET in 1 BOTTLE, PLASTIC (43063-695-95)

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": "41478927-2719-0a32-e063-6294a90acdc9", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0343063695906"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["66f0bf15-ff35-426a-b40c-0d0da79d0861"], "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": "20 TABLET in 1 BOTTLE, PLASTIC (43063-695-20)", "package_ndc": "43063-695-20", "marketing_start_date": "20170221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-695-30)", "package_ndc": "43063-695-30", "marketing_start_date": "20160726"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-695-60)", "package_ndc": "43063-695-60", "marketing_start_date": "20160726"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-695-90)", "package_ndc": "43063-695-90", "marketing_start_date": "20160726"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43063-695-93)", "package_ndc": "43063-695-93", "marketing_start_date": "20160726"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43063-695-95)", "package_ndc": "43063-695-95", "marketing_start_date": "20210222"}], "brand_name": "Famotidine", "product_id": "43063-695_41478927-2719-0a32-e063-6294a90acdc9", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "43063-695", "generic_name": "Famotidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA075805", "marketing_category": "ANDA", "marketing_start_date": "20010416", "listing_expiration_date": "20261231"}