Clopidogrel bisulfate

Product NDC
63739-178
11-digit product format
637390178
Labeler code
63739
Product ID
63739-178_2f97608b-b786-02f3-d5eb-5489e7069f8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA091023
Marketing category
ANDA
Marketing start
2022-08-18
Marketing end
2027-07-31
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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 BISULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08I79HTP27
Rxcui749196

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
63739-178-30Clopidogrel bisulfate5 in 1 CARTONTABLET, FILM COATED54
63739-178-30Clopidogrel bisulfate6 in 1 BLISTER PACKTABLET, FILM COATED64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-178-30EA - Each63739-17835bceadc-9f40-448f-841a-03fdaca90bcb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-178CLOPIDOGREL BISULFATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]4Current NDC, Legacy NDC, 2 package rows20250416_823c5dd0-f4e6-9b45-54de-a609caa8fa90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN823c5dd0-f4e6-9b45-54de-a609caa8fa904
749196clopidogrel 300 MG Oral TabletSCD823c5dd0-f4e6-9b45-54de-a609caa8fa904
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY823c5dd0-f4e6-9b45-54de-a609caa8fa904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-178-30637390178305 BLISTER PACK in 1 CARTON (63739-178-30) / 6 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2022-08-182027-07-31NoNoCurrent