Clopidogrel

Product NDC
16714-052
11-digit product format
167140052
Labeler code
16714
Product ID
16714-052_dbf6d86e-5d4f-40da-a933-b928843053b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202928
Marketing category
ANDA
Marketing start
2022-08-09
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
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-052-01Clopidogrel30 in 1 BOTTLETABLET306
16714-052-02Clopidogrel90 in 1 BOTTLETABLET906
16714-052-03Clopidogrel500 in 1 BOTTLETABLET5006
16714-052-04Clopidogrel1000 in 1 BOTTLETABLET10006
16714-052-10Clopidogrel10 in 1 BLISTER PACKTABLET106
16714-052-11Clopidogrel100 in 1 BOX, UNIT-DOSETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-052CLOPIDOGREL TABLET [NORTHSTAR RXLLC]6Current NDC, Legacy NDC, 6 package rows20241122_d176de1d-b1b3-4aa9-b783-d53f65a79e50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNd176de1d-b1b3-4aa9-b783-d53f65a79e506
309362clopidogrel 75 MG Oral TabletSCDd176de1d-b1b3-4aa9-b783-d53f65a79e506
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYd176de1d-b1b3-4aa9-b783-d53f65a79e506
309362clopidogrel 75 MG Oral TabletPSN3aef6fd4-7160-4678-9362-ca76174bfd0e4
309362clopidogrel 75 MG Oral TabletSCD3aef6fd4-7160-4678-9362-ca76174bfd0e4
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3aef6fd4-7160-4678-9362-ca76174bfd0e4
309362clopidogrel 75 MG Oral TabletPSN3c8c68ca-aa48-43f0-977d-2608e1666be43
309362clopidogrel 75 MG Oral TabletSCD3c8c68ca-aa48-43f0-977d-2608e1666be43
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3c8c68ca-aa48-43f0-977d-2608e1666be43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-052-011671400520130 TABLET in 1 BOTTLE (16714-052-01) 30 tablet2022-08-090000-00-00NoNoCurrent
16714-052-021671400520290 TABLET in 1 BOTTLE (16714-052-02) 90 tablet2022-08-090000-00-00NoNoCurrent
16714-052-0316714005203500 TABLET in 1 BOTTLE (16714-052-03) 500 tablet2022-08-090000-00-00NoNoCurrent
16714-052-04167140052041000 TABLET in 1 BOTTLE (16714-052-04) 1000 tablet2023-04-25NoNoCurrent
16714-052-101671400521010 TABLET in 1 BLISTER PACK (16714-052-10) 10 tablet2022-08-09NoNoCurrent
16714-052-1116714005211100 TABLET in 1 BOX, UNIT-DOSE (16714-052-11) 100 tablet2022-08-090000-00-00NoNoCurrent