Famotidine

Product NDC
68071-3786
11-digit product format
680713786
Labeler code
68071
Product ID
68071-3786_2cde5ba9-3b58-d5eb-e063-6394a90ab920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA215767
Marketing category
ANDA
Marketing start
2021-11-04
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 formatDescriptionMarketing startSampleExclude flagStatus
68071-3786-36807137860330 TABLET, FILM COATED in 1 BOTTLE (68071-3786-3) 2025-01-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FamotidineNuCare Pharmaceuticals, Inc.2025-01-29HUMAN PRESCRIPTION DRUG LABEL2