Famotidine

Product NDC
43063-533
11-digit product format
430630533
Labeler code
43063
Product ID
43063-533_41392bae-3ede-5191-e063-6294a90ac386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075511
Marketing category
ANDA
Marketing start
2001-04-16
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
43063-533-304306305333030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-533-30) 2014-04-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FamotidinePD-Rx Pharmaceuticals, Inc.2025-10-15HUMAN PRESCRIPTION DRUG LABEL22
FamotidinePD-Rx Pharmaceuticals, Inc.2024-10-11HUMAN PRESCRIPTION DRUG LABEL21