FDA.reportPublic FDA data

Clopidogrel

Product NDC
63629-4728
11-digit product format
636294728
Labeler code
63629
Product ID
63629-4728_4a22874a-ae21-4da8-b1c5-6732e9b00825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076999
Marketing category
ANDA
Marketing start
2012-05-17
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
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
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4728-12024-01-30C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-22024-01-30C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-32024-01-30C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-42024-01-30C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-52024-01-30C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-12022-02-16C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-22022-02-16C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-32022-02-16C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-42022-02-16C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-12019-11-27C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-22019-11-27C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-32019-11-27C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
63629-4728-42019-11-27C16284748780-19855e2a2-4c29-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4728-1Clopidogrel90 in 1 BOTTLETABLET, FILM COATED901002
63629-4728-2Clopidogrel30 in 1 BOTTLETABLET, FILM COATED301002
63629-4728-3Clopidogrel60 in 1 BOTTLETABLET, FILM COATED601002
63629-4728-4Clopidogrel20 in 1 BOTTLETABLET, FILM COATED201002
63629-4728-5Clopidogrel10 in 1 BOTTLETABLET, FILM COATED101002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4728CLOPIDOGREL TABLET, FILM COATED [BRYANT RANCH PREPACK]1002Legacy NDC, 5 package rows20220217_4a22874a-ae21-4da8-b1c5-6732e9b00825.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN4a22874a-ae21-4da8-b1c5-6732e9b008251002
309362clopidogrel 75 MG Oral TabletSCD4a22874a-ae21-4da8-b1c5-6732e9b008251002
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY4a22874a-ae21-4da8-b1c5-6732e9b008251002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4728-16362947280190 TABLET, FILM COATED in 1 BOTTLE (63629-4728-1) 2012-05-290000-00-00NoNoCurrent
63629-4728-26362947280230 TABLET, FILM COATED in 1 BOTTLE (63629-4728-2) 2012-08-210000-00-00NoNoCurrent
63629-4728-36362947280360 TABLET, FILM COATED in 1 BOTTLE (63629-4728-3) 2014-07-310000-00-00NoNoCurrent
63629-4728-46362947280420 TABLET, FILM COATED in 1 BOTTLE (63629-4728-4) 2022-02-080000-00-00NoNoCurrent
63629-4728-56362947280510 TABLET, FILM COATED in 1 BOTTLE (63629-4728-5) 2022-02-080000-00-00NoNoCurrent