famotidine

Generic: famotidine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler bluepoint laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-397
Product ID 68001-397_bfda441a-c4ae-7bf3-e053-2a95a90adfe2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206530
Listing Expiration 2026-12-31
Marketing Start 2019-06-19

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 68001397
Hyphenated Format 68001-397

Supplemental Identifiers

RxCUI
284245 310273
UPC
0368001398008
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 ANDA206530 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68001-397-00)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68001-397-08)
source: ndc

Packages (2)

68001-397-00 100 TABLET, FILM COATED in 1 BOTTLE (68001-397-00) 68001-397-08 1000 TABLET, FILM COATED in 1 BOTTLE (68001-397-08)

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": "bfda441a-c4ae-7bf3-e053-2a95a90adfe2", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0368001398008"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["8c7ca3cc-ff90-42a7-9218-554cf15348a3"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68001-397-00)", "package_ndc": "68001-397-00", "marketing_start_date": "20190619"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68001-397-08)", "package_ndc": "68001-397-08", "marketing_start_date": "20190619"}], "brand_name": "Famotidine", "product_id": "68001-397_bfda441a-c4ae-7bf3-e053-2a95a90adfe2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68001-397", "generic_name": "Famotidine", "labeler_name": "BluePoint Laboratories", "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": "20190619", "listing_expiration_date": "20261231"}