FAMOTIDINE

Product NDC
68071-3584
11-digit product format
680713584
Labeler code
68071
Product ID
68071-3584_1316908f-072b-4cbd-e063-6394a90ad4b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA215630
Marketing category
ANDA
Marketing start
2023-08-23
Substance
FAMOTIDINE
Active strength
40 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
68071-3584-36807135840330 TABLET, FILM COATED in 1 BOTTLE (68071-3584-3) 2024-03-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FAMOTIDINENuCare Pharmaceuticals,Inc.2024-03-07HUMAN PRESCRIPTION DRUG LABEL1