FDA.reportPublic FDA data

Famotidine

Product NDC
68071-2842
11-digit product format
680712842
Labeler code
68071
Product ID
68071-2842_ea643663-5ec4-fdc0-e053-2995a90a8f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA216441
Marketing category
ANDA
Marketing start
2022-06-06
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
68071-2842-32025-01-30C16284748780-12cef2736-b2d2-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
68071-2842-82025-01-30C16284748780-12cef2736-b2d2-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
68071-2842-3Famotidine30 in 1 BOTTLETABLET, FILM COATED302
68071-2842-8Famotidine180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2842FAMOTIDINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230526_ea643663-5ec5-fdc0-e053-2995a90a8f97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNea643663-5ec5-fdc0-e053-2995a90a8f972
310273famotidine 20 MG Oral TabletSCDea643663-5ec5-fdc0-e053-2995a90a8f972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2842-36807128420330 in 1 BOTTLEHistorical
68071-2842-868071284208180 TABLET, FILM COATED in 1 BOTTLE (68071-2842-8) 2022-10-060000-00-00NoNoCurrent