FDA.reportPublic FDA data

Famotidine

Product NDC
53002-1199
11-digit product format
530021199
Labeler code
53002
Product ID
53002-1199_d92c32ff-185e-4ff2-8cb7-8c8cbf468efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1199-02023-01-30C16284748780-19d75b9d1-1e5a-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
53002-1199-22023-01-30C16284748780-19d75b9d1-1e5a-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
53002-1199-32023-01-30C16284748780-19d75b9d1-1e5a-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
53002-1199-52023-01-30C16284748780-19d75b9d1-1e5a-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
53002-1199-62023-01-30C16284748780-19d75b9d1-1e5a-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
53002-1199-02020-12-16C16284748780-19d75b9d1-1e5a-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
53002-1199-22020-12-16C16284748780-19d75b9d1-1e5a-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
53002-1199-32020-12-16C16284748780-19d75b9d1-1e5a-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
53002-1199-52020-12-16C16284748780-19d75b9d1-1e5a-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
53002-1199-62020-12-16C16284748780-19d75b9d1-1e5a-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
53002-1199-02020-01-31C16284748780-19d75b9d1-1e5a-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
53002-1199-22020-01-31C16284748780-19d75b9d1-1e5a-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
53002-1199-32020-01-31C16284748780-19d75b9d1-1e5a-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
53002-1199-52020-01-31C16284748780-19d75b9d1-1e5a-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
53002-1199-62020-01-31C16284748780-19d75b9d1-1e5a-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
53002-1199-0Famotidine100 in 1 BOTTLETABLET1003
53002-1199-2Famotidine20 in 1 BOTTLETABLET203
53002-1199-3Famotidine30 in 1 BOTTLETABLET303
53002-1199-5Famotidine15 in 1 BOTTLETABLET153
53002-1199-6Famotidine60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1199FAMOTIDINE TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 5 package rows20201217_3ed93a3b-fefc-40cf-aeac-7ef38844a539.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN3ed93a3b-fefc-40cf-aeac-7ef38844a5393
310273famotidine 20 MG Oral TabletSCD3ed93a3b-fefc-40cf-aeac-7ef38844a5393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1199-053002119900100 TABLET in 1 BOTTLE (53002-1199-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1199-25300211990220 TABLET in 1 BOTTLE (53002-1199-2) 20 tablet2017-09-010000-00-00NoNoCurrent
53002-1199-35300211990330 TABLET in 1 BOTTLE (53002-1199-3) 30 tablet2017-09-010000-00-00NoNoCurrent
53002-1199-55300211990515 TABLET in 1 BOTTLE (53002-1199-5) 15 tablet2017-09-010000-00-00NoNoCurrent
53002-1199-65300211990660 TABLET in 1 BOTTLE (53002-1199-6) 60 tablet2017-09-010000-00-00NoNoCurrent