FDA.reportPublic FDA data

CLOPIDOGREL

Product NDC
72205-199
11-digit product format
722050199
Labeler code
72205
Product ID
72205-199_0b4edca9-12af-4534-baad-4fa5c1cc9ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL BISULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215388
Marketing category
ANDA
Marketing start
2024-09-20
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
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
72205-199-01CLOPIDOGREL1000 in 1 BOTTLETABLET, FILM COATED10002
72205-199-05CLOPIDOGREL500 in 1 BOTTLETABLET, FILM COATED5002
72205-199-06CLOPIDOGREL10 in 1 CARTONTABLET, FILM COATED102
72205-199-11CLOPIDOGREL10 in 1 BLISTER PACKTABLET, FILM COATED102
72205-199-30CLOPIDOGREL30 in 1 BOTTLETABLET, FILM COATED302
72205-199-90CLOPIDOGREL90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-199-01EA - Each72205-1992bd60ca5-64ca-4783-bb7d-c1a1c97e47d612025-11-13
72205-199-05EA - Each72205-1990c3da073-c3a3-4950-9b58-b6567b7678eb12025-02-10
72205-199-30EA - Each72205-19967cfaeae-7b6f-43ac-afd8-6d65e5848ea112025-02-10
72205-199-90EA - Each72205-19973564052-862c-42de-80d9-6acf27cd458e12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-199CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 6 package rows20241123_1447a095-c663-4f05-91d4-f09bfc0c3d42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN1447a095-c663-4f05-91d4-f09bfc0c3d422
309362clopidogrel 75 MG Oral TabletSCD1447a095-c663-4f05-91d4-f09bfc0c3d422
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY1447a095-c663-4f05-91d4-f09bfc0c3d422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-199-01722050199011000 TABLET, FILM COATED in 1 BOTTLE (72205-199-01) 2025-11-12NoNoCurrent
72205-199-0572205019905500 TABLET, FILM COATED in 1 BOTTLE (72205-199-05) 2024-11-22NoNoCurrent
72205-199-067220501990610 BLISTER PACK in 1 CARTON (72205-199-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-199-11) 10 blister pack2024-11-22NoNoCurrent
72205-199-117220501991110 in 1 BLISTER PACKHistorical
72205-199-307220501993030 TABLET, FILM COATED in 1 BOTTLE (72205-199-30) 2024-11-22NoNoCurrent
72205-199-907220501999090 TABLET, FILM COATED in 1 BOTTLE (72205-199-90) 2024-11-22NoNoCurrent