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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3199-0Famotidine100 in 1 BOTTLETABLET1001
53002-3199-2Famotidine20 in 1 BOTTLETABLET201
53002-3199-3Famotidine30 in 1 BOTTLETABLET301
53002-3199-5Famotidine15 in 1 BOTTLETABLET151
53002-3199-6Famotidine60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3199FAMOTIDINE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20220331_bfc9e530-3433-4fed-a542-0e64123cddfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNbfc9e530-3433-4fed-a542-0e64123cddfb1
310273famotidine 20 MG Oral TabletSCDbfc9e530-3433-4fed-a542-0e64123cddfb1

Packages#

Package NDC, 11-digit format, Description table
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