FAMOTIDINE

Product NDC
68071-3420
11-digit product format
680713420
Labeler code
68071
Product ID
68071-3420_1bf9ddc8-fe69-c02a-e063-6394a90a7149
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
2022-07-08
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
68071-3420-36807134200330 TABLET, FILM COATED in 1 BOTTLE (68071-3420-3) 2023-07-26NoNoHistorical
68071-3420-66807134200660 TABLET, FILM COATED in 1 BOTTLE (68071-3420-6) 2023-06-01NoNoHistorical
68071-3420-76807134200714 TABLET, FILM COATED in 1 BOTTLE (68071-3420-7) 2023-07-26NoNoHistorical
68071-3420-868071342008120 TABLET, FILM COATED in 1 BOTTLE (68071-3420-8) 2023-07-26NoNoHistorical
68071-3420-96807134200990 TABLET, FILM COATED in 1 BOTTLE (68071-3420-9) 2023-07-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FAMOTIDINENuCare Pharmaceuticals,Inc.2024-06-28HUMAN PRESCRIPTION DRUG LABEL5