Famotidine

Product NDC
83008-091
11-digit product format
830080091
Labeler code
83008
Product ID
83008-091_2bfb16cd-192b-4b00-aef4-77d1b927fea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA075718
Marketing category
ANDA
Marketing start
2024-09-18
Marketing end
2026-12-31
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5QZO15J2Z8FAMOTIDINE76824-35-6FAMOTIDINE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-091-308300800913030 TABLET, FILM COATED in 1 BOTTLE (83008-091-30) 2024-09-182026-12-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FamotidineQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL4