FDA.reportPublic FDA data

Clopidogrel

Product NDC
54458-888
11-digit product format
544580888
Labeler code
54458
Product ID
54458-888_4e3ae543-f321-464c-a4c0-579ddd6cc462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076999
Marketing category
ANDA
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
54458-888-102020-09-27C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-162020-09-27C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-102020-09-25C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-162020-09-25C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-102020-07-22C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-162020-07-22C16284748780-1ab0e2407-2f90-f274-e053-dbdaa90a6471These 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
54458-888-10Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3013
54458-888-16Clopidogrel30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-888-10EA - Each54458-8881447070c-6c98-45fd-9438-ff362dee9dc412014-02-04
54458-888-16EA - Each54458-88877b77766-7f58-4842-976a-6454da941d1a12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
LACTOSE, UNSPECIFIED FORMINACTIVE INGREDIENTJ2B2A4N98GCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-888CLOPIDOGREL TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]13Legacy NDC, 2 package rows20191219_3dd041b8-abf7-4e19-96bb-b3cc8b5603b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN3dd041b8-abf7-4e19-96bb-b3cc8b5603b513
309362clopidogrel 75 MG Oral TabletSCD3dd041b8-abf7-4e19-96bb-b3cc8b5603b513
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3dd041b8-abf7-4e19-96bb-b3cc8b5603b513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-888-105445808881030 in 1 BLISTER PACKHistorical
54458-888-165445808881630 in 1 BOTTLEHistorical