Famotidine

Product NDC
71610-399
11-digit product format
716100399
Labeler code
71610
Product ID
71610-399_ce00f657-538e-4b73-9126-1cff453be4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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
71610-399-307161003993030 TABLET in 1 BOTTLE (71610-399-30) 30 tablet2020-06-23NoNoHistorical
71610-399-607161003996090 TABLET in 1 BOTTLE (71610-399-60) 90 tablet2020-02-21NoNoHistorical
71610-399-8071610039980180 TABLET in 1 BOTTLE (71610-399-80) 180 tablet2020-02-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FamotidineAphena Pharma Solutions - Tennessee, LLC2020-07-06Human Prescription Drug Label2