FDA.reportPublic FDA data

CLOPIDOGREL

Product NDC
71717-101
11-digit product format
717170101
Labeler code
71717
Product ID
71717-101_64a57a2c-f2e0-416c-e053-2991aa0af2be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL
Dosage form
TABLET
Route
ORAL
Labeler
Megalith Pharmaceuticals Inc
Application
ANDA204359
Marketing category
ANDA
Marketing start
2017-12-01
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71717-101-032020-01-31C16284748780-19d75b9d0-6865-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
71717-101-092020-01-31C16284748780-19d75b9d0-6865-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
71717-101-502020-01-31C16284748780-19d75b9d0-6865-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71717-101-03CLOPIDOGREL30 in 1 BOTTLE, PLASTICTABLET307
71717-101-09CLOPIDOGREL90 in 1 BOTTLE, PLASTICTABLET907
71717-101-50CLOPIDOGREL500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71717-101-03EA - Each71717-1019f18b307-9792-41fb-b070-436e36c10d3f12018-02-20
71717-101-09EA - Each71717-101b6487b00-ced2-4050-863f-e8e4d66b57ca12018-02-20
71717-101-50EA - Each71717-10123f5ed78-f072-45fb-b32c-cdb403de1c5a12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71717-101CLOPIDOGREL TABLET [MEGALITH PHARMACEUTICALS INC]7Legacy NDC, 3 package rows20180208_5903a773-7f31-3223-e053-2991aa0ac983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN5903a773-7f31-3223-e053-2991aa0ac9837
309362clopidogrel 75 MG Oral TabletSCD5903a773-7f31-3223-e053-2991aa0ac9837
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY5903a773-7f31-3223-e053-2991aa0ac9837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71717-101-037171701010330 in 1 BOTTLE, PLASTICHistorical
71717-101-097171701010990 in 1 BOTTLE, PLASTICHistorical
71717-101-5071717010150500 in 1 BOTTLE, PLASTICHistorical