Clopidogrel bisulfate

Product NDC
68788-7700
11-digit product format
687887700
Labeler code
68788
Product ID
68788-7700_e5db9ade-b4b9-4451-bb59-aec61dc2b124
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2020-05-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel bisulfate
Listing expiration
2027-12-31

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
68788-7700-3Clopidogrel bisulfate30 in 1 BOTTLETABLET, FILM COATED307
68788-7700-6Clopidogrel bisulfate60 in 1 BOTTLETABLET, FILM COATED607
68788-7700-9Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7700-3EA - Each68788-770052b17037-52cf-41c4-b317-aaf16d545f5812020-08-06
68788-7700-6EA - Each68788-77002e3ec283-fa49-410f-85e1-17f9f0562b4212020-08-06
68788-7700-9EA - Each68788-7700aefa34af-d754-4ce4-b764-5149f1179f0912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7700CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20250309_e51d4bcc-01df-409d-9179-45e6536ac25b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSNe51d4bcc-01df-409d-9179-45e6536ac25b7
309362clopidogrel 75 MG Oral TabletSCDe51d4bcc-01df-409d-9179-45e6536ac25b7
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYe51d4bcc-01df-409d-9179-45e6536ac25b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7700-36878877000330 TABLET, FILM COATED in 1 BOTTLE (68788-7700-3) 2020-05-010000-00-00NoNoCurrent
68788-7700-66878877000660 TABLET, FILM COATED in 1 BOTTLE (68788-7700-6) 2020-05-010000-00-00NoNoCurrent
68788-7700-96878877000990 TABLET, FILM COATED in 1 BOTTLE (68788-7700-9) 2020-05-010000-00-00NoNoCurrent