Clopidogrel

Product NDC
0904-6467
11-digit product format
009046467
Labeler code
0904
Product ID
0904-6467_188c5658-7bc2-4331-a794-a2194863953c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076274
Marketing category
ANDA
Marketing start
2015-04-06
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
Rxcui749196

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
0904-6467-07Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED110
0904-6467-07Clopidogrel30 in 1 CARTONTABLET, FILM COATED3010
0904-6467-10Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED110
0904-6467-10Clopidogrel20 in 1 CARTONTABLET, FILM COATED2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6467-07EA - Each0904-64676f45241e-4cfa-431b-84b0-0b614631dd8712015-05-05
0904-6467-10EA - Each0904-64673758bd5d-fe11-4df3-bf31-f2df430dcad112021-06-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6467CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20241012_4cd07a3c-9673-4aa0-b76a-d79df2399ee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6467-070090464670730 BLISTER PACK in 1 CARTON (0904-6467-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2015-04-060000-00-00NoNoCurrent
0904-6467-100090464671020 BLISTER PACK in 1 CARTON (0904-6467-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK20 blister pack2015-04-060000-00-00NoNoCurrent