FDA.reportPublic FDA data

Famotidine

Product NDC
53002-2199
11-digit product format
530022199
Labeler code
53002
Product ID
53002-2199_467c3e18-cc41-4835-b8c1-709e65dce5b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2199-02025-01-30C16284748780-12cef2736-8245-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
53002-2199-22025-01-30C16284748780-12cef2736-8245-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
53002-2199-32025-01-30C16284748780-12cef2736-8245-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
53002-2199-52025-01-30C16284748780-12cef2736-8245-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
53002-2199-62025-01-30C16284748780-12cef2736-8245-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2199-0Famotidine100 in 1 BOTTLETABLET, FILM COATED1004
53002-2199-2Famotidine20 in 1 BOTTLETABLET, FILM COATED204
53002-2199-3Famotidine30 in 1 BOTTLETABLET, FILM COATED304
53002-2199-5Famotidine15 in 1 BOTTLETABLET, FILM COATED154
53002-2199-6Famotidine60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2199FAMOTIDINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 5 package rows20220331_dfa8f480-1a57-422d-b584-4f27277dc700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNdfa8f480-1a57-422d-b584-4f27277dc7004
310273famotidine 20 MG Oral TabletSCDdfa8f480-1a57-422d-b584-4f27277dc7004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2199-053002219900100 TABLET, FILM COATED in 1 BOTTLE (53002-2199-0) 2021-01-010000-00-00NoNoCurrent
53002-2199-25300221990220 TABLET, FILM COATED in 1 BOTTLE (53002-2199-2) 2021-01-010000-00-00NoNoCurrent
53002-2199-35300221990330 TABLET, FILM COATED in 1 BOTTLE (53002-2199-3) 2021-01-010000-00-00NoNoCurrent
53002-2199-55300221990515 TABLET, FILM COATED in 1 BOTTLE (53002-2199-5) 2021-01-010000-00-00NoNoCurrent
53002-2199-65300221990660 TABLET, FILM COATED in 1 BOTTLE (53002-2199-6) 2021-01-010000-00-00NoNoCurrent