Famotidine

Product NDC
46122-737
11-digit product format
461220737
Labeler code
46122
Product ID
46122-737_d51e75bd-4703-4fc4-b5cd-94b17f72b9a6
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA206531
Marketing category
ANDA
Marketing start
2023-07-20
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5QZO15J2Z8FAMOTIDINE76824-35-6FAMOTIDINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-737-63461220737631 BOTTLE in 1 CARTON (46122-737-63) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-20NoNoHistorical
46122-737-71461220737711 BOTTLE in 1 CARTON (46122-737-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Famotidine - Amerisource Bergen | Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma LimitedAmerisource Bergen | Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited2025-04-22Human OTC Drug Label3