FDA.reportPublic FDA data

Clopidogrel bisulfate

Product NDC
82009-021
11-digit product format
820090021
Labeler code
82009
Product ID
82009-021_e8fadba0-80b2-f6fd-ba68-512d796e5d89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA076273
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel bisulfate

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
82009-021-05Clopidogrel bisulfate500 in 1 BOTTLETABLET, FILM COATED5004
82009-021-90Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-021-05EA - Each82009-0211619cf98-cc34-4cd7-99eb-4dcf4873530212023-01-09
82009-021-90EA - Each82009-02156e010b8-3326-42cc-80b6-215dd8a3a0a412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-021CLOPIDOGREL BISULFATE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20240314_333c7992-d481-b7d4-404f-9a49c85b6331.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN333c7992-d481-b7d4-404f-9a49c85b63314
309362clopidogrel 75 MG Oral TabletSCD333c7992-d481-b7d4-404f-9a49c85b63314
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY333c7992-d481-b7d4-404f-9a49c85b63314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-021-0582009002105500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) 2022-11-152027-02-28NoNoCurrent
82009-021-908200900219090 TABLET, FILM COATED in 1 BOTTLE (82009-021-90) 2022-11-150000-00-00NoNoCurrent