FDA.reportPublic FDA data

Clopidogrel

Product NDC
60505-3532
11-digit product format
605053532
Labeler code
60505
Product ID
60505-3532_936a8707-dc3c-ebe4-6a66-0f726988c764
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA076274
Marketing category
ANDA
Marketing start
2014-03-04
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362, 749196

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3532-5Clopidogrel500 in 1 BOTTLETABLET, FILM COATED50026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3532-5EA - Each60505-3532dbb6eef9-2386-4038-9c38-4fa4ba047e1d12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]9
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3532CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]25Current NDC, Legacy NDC, 1 package rows20240925_edae8df1-caf9-ff72-1304-5ae8b355f8e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNedae8df1-caf9-ff72-1304-5ae8b355f8e726
309362clopidogrel 75 MG Oral TabletPSNedae8df1-caf9-ff72-1304-5ae8b355f8e726
749196clopidogrel 300 MG Oral TabletSCDedae8df1-caf9-ff72-1304-5ae8b355f8e726
309362clopidogrel 75 MG Oral TabletSCDedae8df1-caf9-ff72-1304-5ae8b355f8e726
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYedae8df1-caf9-ff72-1304-5ae8b355f8e726
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYedae8df1-caf9-ff72-1304-5ae8b355f8e726
749196clopidogrel 300 MG Oral TabletPSN65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG Oral TabletPSN65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
749196clopidogrel 300 MG Oral TabletSCD65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG Oral TabletSCD65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY65ea4dc6-acb2-4609-9a4c-4866ef0ccb1113
749196clopidogrel 300 MG Oral TabletPSN4cd07a3c-9673-4aa0-b76a-d79df2399ee110
749196clopidogrel 300 MG Oral TabletSCD4cd07a3c-9673-4aa0-b76a-d79df2399ee110
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY4cd07a3c-9673-4aa0-b76a-d79df2399ee110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3532-560505353205500 TABLET, FILM COATED in 1 BOTTLE (60505-3532-5) 2014-03-040000-00-00NoNoCurrent