FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
43598-121
11-digit product format
435980121
Labeler code
43598
Product ID
43598-121_76e9fa8d-c829-37b1-814e-844d436b7784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA091023
Marketing category
ANDA
Marketing start
2025-04-15
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 bisulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 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
43598-121-05Clopidogrel bisulfate500 in 1 BOTTLETABLET, FILM COATED5003
43598-121-10Clopidogrel bisulfate1000 in 1 BOTTLETABLET, FILM COATED10003
43598-121-30Clopidogrel bisulfate30 in 1 BOTTLETABLET, FILM COATED303
43598-121-90Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-121-05EA - Each43598-1217445d308-d077-4126-aa49-6961e63ff1c912025-09-12
43598-121-30EA - Each43598-12183f359aa-3a34-4c6d-9a32-ff65e9098d8512025-09-12
43598-121-90EA - Each43598-12150d850ba-0261-4f44-9343-7a3219e2eed812025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-121CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]3Current NDC, 4 package rows20250416_45caaa95-8470-b459-5f82-8156072d1878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN45caaa95-8470-b459-5f82-8156072d18783
309362clopidogrel 75 MG Oral TabletPSN45caaa95-8470-b459-5f82-8156072d18783
749196clopidogrel 300 MG Oral TabletSCD45caaa95-8470-b459-5f82-8156072d18783
309362clopidogrel 75 MG Oral TabletSCD45caaa95-8470-b459-5f82-8156072d18783
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY45caaa95-8470-b459-5f82-8156072d18783
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY45caaa95-8470-b459-5f82-8156072d18783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-121-0543598012105500 TABLET, FILM COATED in 1 BOTTLE (43598-121-05) 2025-04-15NoNoCurrent
43598-121-10435980121101000 TABLET, FILM COATED in 1 BOTTLE (43598-121-10) 2025-04-15NoNoCurrent
43598-121-304359801213030 TABLET, FILM COATED in 1 BOTTLE (43598-121-30) 2025-04-15NoNoCurrent
43598-121-904359801219090 TABLET, FILM COATED in 1 BOTTLE (43598-121-90) 2025-04-15NoNoCurrent