FDA.reportPublic FDA data

Famotidine

Product NDC
53002-6670
11-digit product format
530026670
Labeler code
53002
Product ID
53002-6670_108790ff-607f-4326-9954-a76ade0f85e7
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
40 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-6670-12025-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-22025-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-32025-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-62025-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-12023-06-08C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-22023-06-08C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-32023-06-08C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-62023-06-08C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-12023-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-22023-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-32023-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-62023-01-30C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-12020-12-17C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-22020-12-17C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-32020-12-17C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-62020-12-17C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-12020-01-31C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-22020-01-31C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-32020-01-31C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-62020-01-31C16284748780-19d75b9d1-145b-f424-e053-dadaa90a57ceThese 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
53002-6670-1Famotidine10 in 1 BOTTLETABLET, FILM COATED105
53002-6670-2Famotidine20 in 1 BOTTLETABLET, FILM COATED205
53002-6670-3Famotidine30 in 1 BOTTLETABLET, FILM COATED305
53002-6670-6Famotidine60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6670FAMOTIDINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_ba35f425-9321-4fd8-91d4-053a1edb3a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNba35f425-9321-4fd8-91d4-053a1edb3a055
284245famotidine 40 MG Oral TabletSCDba35f425-9321-4fd8-91d4-053a1edb3a055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-6670-15300266700110 TABLET, FILM COATED in 1 BOTTLE (53002-6670-1) 2018-10-010000-00-00NoNoCurrent
53002-6670-25300266700220 TABLET, FILM COATED in 1 BOTTLE (53002-6670-2) 2018-10-010000-00-00NoNoCurrent
53002-6670-35300266700330 TABLET, FILM COATED in 1 BOTTLE (53002-6670-3) 2018-10-010000-00-00NoNoCurrent
53002-6670-65300266700660 TABLET, FILM COATED in 1 BOTTLE (53002-6670-6) 2018-10-010000-00-00NoNoCurrent