FDA.reportPublic FDA data

Clopidogrel

Product NDC
50268-184
11-digit product format
502680184
Labeler code
50268
Product ID
50268-184_486110ba-88b3-80cc-e063-6294a90a28b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA204165
Marketing category
ANDA
Marketing start
2019-10-11
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
50268-184-11Clopidogrel1 in 1 BLISTER PACKTABLET, FILM COATED15
50268-184-12Clopidogrel20 in 1 BOXTABLET, FILM COATED205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-184-11EA - Each50268-1841af0b068-5a07-46db-b62b-558d5d7d3eae12019-11-12
50268-184-12EA - Each50268-184c45df330-f2d8-48aa-8b86-653b8421c2ac12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-184CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_94a5cdc4-e063-1d46-e053-2995a90a7e15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN94a5cdc4-e063-1d46-e053-2995a90a7e155
749196clopidogrel 300 MG Oral TabletSCD94a5cdc4-e063-1d46-e053-2995a90a7e155
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY94a5cdc4-e063-1d46-e053-2995a90a7e155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-184-11502680184111 in 1 BLISTER PACKHistorical
50268-184-125026801841220 BLISTER PACK in 1 BOX (50268-184-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-184-11) 20 blister pack2019-10-110000-00-00NoNoCurrent