FDA.reportPublic FDA data

CLOPIDOGREL

Product NDC
67877-276
11-digit product format
678770276
Labeler code
67877
Product ID
67877-276_04c45152-3a50-45e1-9edb-2ddf3ed43988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL BISULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA203632
Marketing category
ANDA
Marketing start
2024-05-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOPIDOGREL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui309362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-276-05CLOPIDOGREL500 in 1 BOTTLETABLET5008
67877-276-30CLOPIDOGREL30 in 1 BOTTLETABLET308
67877-276-90CLOPIDOGREL90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-276-05EA - Each67877-276f04ead37-2c78-448b-9890-759fb887460812024-07-12
67877-276-90EA - Each67877-2769d2a32b5-a8b3-4d90-8314-0b501dae1db212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-276CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET [ASCEND LABORATORIES, LLC]8Current NDC, 3 package rows20240518_db1161c9-6efd-4361-a766-6a37c241ccee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321
309362clopidogrel 75 MG Oral TabletPSN669f0bc6-f173-484d-8efe-c006683b25d11
309362clopidogrel 75 MG Oral TabletPSNffeb2fca-d475-4d93-913d-0048ff9fcee91
309362clopidogrel 75 MG Oral TabletSCD2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321
309362clopidogrel 75 MG Oral TabletSCD669f0bc6-f173-484d-8efe-c006683b25d11
309362clopidogrel 75 MG Oral TabletSCDffeb2fca-d475-4d93-913d-0048ff9fcee91
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2564e8ee-fa2d-49d1-9a1a-6f3eb1e740321
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY669f0bc6-f173-484d-8efe-c006683b25d11
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYffeb2fca-d475-4d93-913d-0048ff9fcee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-276-0567877027605500 TABLET in 1 BOTTLE (67877-276-05) 500 tablet2024-05-16NoNoCurrent
67877-276-306787702763030 TABLET in 1 BOTTLE (67877-276-30) 30 tablet2024-05-16NoNoCurrent
67877-276-906787702769090 TABLET in 1 BOTTLE (67877-276-90) 90 tablet2024-05-16NoNoCurrent