FDA.reportPublic FDA data

Clopidogrel

Product NDC
71205-073
11-digit product format
712050073
Labeler code
71205
Product ID
71205-073_3d0c235a-ed00-4295-91a1-c0af34ff07a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
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
71205-073-30Clopidogrel30 in 1 BOTTLETABLET, FILM COATED304
71205-073-60Clopidogrel60 in 1 BOTTLETABLET, FILM COATED604
71205-073-90Clopidogrel90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-073-30EA - Each71205-0736e1a6f8e-76ed-4499-bcbd-214d5afee21412018-12-13
71205-073-90EA - Each71205-07366773bf2-0237-4a97-8e77-ca478885cf3212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-073CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220421_ec296eed-81d0-4c1e-bff4-431851899157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNec296eed-81d0-4c1e-bff4-4318518991574
309362clopidogrel 75 MG Oral TabletSCDec296eed-81d0-4c1e-bff4-4318518991574
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYec296eed-81d0-4c1e-bff4-4318518991574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-073-307120500733030 TABLET, FILM COATED in 1 BOTTLE (71205-073-30) 2018-07-020000-00-00NoNoCurrent
71205-073-607120500736060 TABLET, FILM COATED in 1 BOTTLE (71205-073-60) 2018-07-020000-00-00NoNoCurrent
71205-073-907120500739090 TABLET, FILM COATED in 1 BOTTLE (71205-073-90) 2018-07-020000-00-00NoNoCurrent