famotidine

Generic: famotidine

Labeler: precision dose, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler precision dose, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-054
Product ID 68094-054_85fb9c19-0c02-4c0e-8f80-ecead1578723
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077351
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

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 68094054
Hyphenated Format 68094-054

Supplemental Identifiers

RxCUI
310273
UPC
0368094054652
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 ANDA077351 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (68094-054-65) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-054-59)
source: ndc

Packages (1)

68094-054-65 20 BLISTER PACK in 1 CARTON (68094-054-65) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-054-59)

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": "85fb9c19-0c02-4c0e-8f80-ecead1578723", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0368094054652"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["de42b6c4-c44b-4ec1-b505-fc5266452d57"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (68094-054-65)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-054-59)", "package_ndc": "68094-054-65", "marketing_start_date": "20240328"}], "brand_name": "Famotidine", "product_id": "68094-054_85fb9c19-0c02-4c0e-8f80-ecead1578723", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68094-054", "generic_name": "FAMOTIDINE", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA077351", "marketing_category": "ANDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}