Famotidine

Product NDC
53002-3199
11-digit product format
530023199
Labeler code
53002
Product ID
53002-3199_f4b4c736-a965-4536-ac53-e58f5bdf5559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5QZO15J2Z8FAMOTIDINE76824-35-6FAMOTIDINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3199-053002319900100 TABLET in 1 BOTTLE (53002-3199-0) 100 tablet2021-01-010000-00-00NoNoCurrent
53002-3199-25300231990220 TABLET in 1 BOTTLE (53002-3199-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-3199-35300231990330 TABLET in 1 BOTTLE (53002-3199-3) 30 tablet2021-01-010000-00-00NoNoCurrent
53002-3199-55300231990515 TABLET in 1 BOTTLE (53002-3199-5) 15 tablet2021-01-010000-00-00NoNoCurrent
53002-3199-65300231990660 TABLET in 1 BOTTLE (53002-3199-6) 60 tablet2021-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Famotidine Tablets USPRPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL1