Famotidine

Product NDC
46122-735
11-digit product format
461220735
Labeler code
46122
Product ID
46122-735_791e2d0f-6c6d-4b46-9b4b-a672a7452967
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA206531
Marketing category
ANDA
Marketing start
2023-07-27
Substance
FAMOTIDINE
Active strength
10 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
46122-735-65461220735651 BOTTLE in 1 CARTON (46122-735-65) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-28NoNoHistorical
46122-735-75461220735751 BOTTLE in 1 CARTON (46122-735-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Famotidine - Amerisource Bergen | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDAmerisource Bergen | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-03-28Human OTC Drug Label3