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, COATED
Routes
ORAL
Active Ingredients

famotidine 40 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-981
Product ID 82804-981_7335a9b3-33fb-4343-bc31-b26dd58c0a1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217669
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

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 82804981
Hyphenated Format 82804-981

Supplemental Identifiers

RxCUI
284245 310273
UPC
0382804981205 0382804980208
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 ANDA217669 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-00)
  • 20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-20)
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-30)
  • 500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-55)
  • 60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-60)
  • 270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-67)
  • 120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-72)
  • 180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-78)
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-90)
source: ndc

Packages (9)

82804-981-00 100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-00) 82804-981-20 20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-20) 82804-981-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-30) 82804-981-55 500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-55) 82804-981-60 60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-60) 82804-981-67 270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-67) 82804-981-72 120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-72) 82804-981-78 180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-78) 82804-981-90 90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-90)

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": "7335a9b3-33fb-4343-bc31-b26dd58c0a1c", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0382804981205", "0382804980208"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["c7327748-835b-44df-848f-8c620d327ce6"], "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": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-00)", "package_ndc": "82804-981-00", "marketing_start_date": "20250127"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-20)", "package_ndc": "82804-981-20", "marketing_start_date": "20250127"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-30)", "package_ndc": "82804-981-30", "marketing_start_date": "20250127"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-55)", "package_ndc": "82804-981-55", "marketing_start_date": "20250127"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-60)", "package_ndc": "82804-981-60", "marketing_start_date": "20250127"}, {"sample": false, "description": "270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-67)", "package_ndc": "82804-981-67", "marketing_start_date": "20250127"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-72)", "package_ndc": "82804-981-72", "marketing_start_date": "20250127"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-78)", "package_ndc": "82804-981-78", "marketing_start_date": "20250127"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-90)", "package_ndc": "82804-981-90", "marketing_start_date": "20250127"}], "brand_name": "Famotidine", "product_id": "82804-981_7335a9b3-33fb-4343-bc31-b26dd58c0a1c", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "82804-981", "generic_name": "Famotidine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA217669", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20261231"}