Rugby Famotidine

Product NDC
0536-1298
11-digit product format
005361298
Labeler code
0536
Product ID
0536-1298_12c5ddd1-e203-4e79-ab9b-5fab9bb7933a
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA077351
Marketing category
ANDA
Marketing start
2020-09-14
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
0536-1298-01005361298011 BOTTLE in 1 CARTON (0536-1298-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rugby Laboratories Famotidine Drug FactsRugby Laboratories2025-08-13HUMAN OTC DRUG LABEL4