Clopidogrel

Product NDC
68084-752
11-digit product format
680840752
Labeler code
68084
Product ID
68084-752_2c3a4450-fdb9-1ef8-e063-6294a90ab226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076274
Marketing category
ANDA
Marketing start
2014-03-28
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
68084-752-18Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED113
68084-752-19Clopidogrel20 in 1 CARTONTABLET, FILM COATED2013
68084-752-25Clopidogrel30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3013
68084-752-95Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-752-18EA - Each68084-7527a83aaf4-ec86-4f4d-bfb5-efadcaf273bb12023-07-06
68084-752-19EA - Each68084-752581e3cda-1848-4a29-a775-a52bcd890af712023-07-06
68084-752-25EA - Each68084-752ec2e3887-b5ba-4a66-9079-fd62c34536ef12015-08-04
68084-752-95EA - Each68084-75234980771-9dfd-400c-89e7-26ee23d9f7d112015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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 [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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
68084-752CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]13Current NDC, Legacy NDC, 4 package rows20250122_65ea4dc6-acb2-4609-9a4c-4866ef0ccb11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-752-18680840752181 in 1 BLISTER PACKHistorical
68084-752-196808407521920 BLISTER PACK in 1 CARTON (68084-752-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-18) 20 blister pack2023-07-12NoNoHistorical
68084-752-256808407522530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-752-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-95) 30 blister pack2014-03-310000-00-00NoNoCurrent
68084-752-95680840752951 in 1 BLISTER PACKHistorical