Famotidine

Product NDC
71610-470
11-digit product format
716100470
Labeler code
71610
Product ID
71610-470_cd18c7ed-b8ed-45a8-accb-f1baa08f0a5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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
71610-470-537161004705360 TABLET in 1 BOTTLE, PLASTIC (71610-470-53) 60 tablet2021-04-07NoNoHistorical
71610-470-607161004706090 TABLET in 1 BOTTLE, PLASTIC (71610-470-60) 90 tablet2020-10-09NoNoHistorical
71610-470-8071610047080180 TABLET in 1 BOTTLE, PLASTIC (71610-470-80) 180 tablet2020-10-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Famotidine Tablets USPAphena Pharma Solutions - Tennessee, LLC2021-05-18HUMAN PRESCRIPTION DRUG LABEL2