Clopidogrel

Product NDC
82804-986
11-digit product format
828040986
Labeler code
82804
Product ID
82804-986_330702d9-842c-416d-9b11-b4a9b707e9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204165
Marketing category
ANDA
Marketing start
2018-07-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2026-12-31

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
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
82804-986-00Clopidogrel100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
82804-986-30Clopidogrel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
82804-986-55Clopidogrel500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
82804-986-60Clopidogrel60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
82804-986-64Clopidogrel240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2401
82804-986-72Clopidogrel120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
82804-986-78Clopidogrel180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
82804-986-90Clopidogrel90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-986-00EA - Each82804-986cb737fb9-37eb-4810-aa7a-920f9d1814cf12024-07-12
82804-986-30EA - Each82804-9868bf298e9-21a4-4c1b-ae9f-53f3aae98e9912024-07-12
82804-986-55EA - Each82804-986135a67fe-6938-497c-8e09-35f5c146e4d812024-07-12
82804-986-60EA - Each82804-986e24be14a-27e8-4f9d-abfc-7474f428ef2d12024-07-12
82804-986-64EA - Each82804-986d7021643-9bda-4598-92b2-b04a3ecc37e812024-07-12
82804-986-72EA - Each82804-986f4d6924a-d27a-4938-b38a-1ec65a50c88012024-07-12
82804-986-78EA - Each82804-9865580459a-b1b4-45b8-bc8e-7075413ec92112024-07-12
82804-986-90EA - Each82804-986e154dfb8-1001-4397-ab5c-5c97fd77035512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-986CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 8 package rows20240522_330702d9-842c-416d-9b11-b4a9b707e9b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG Oral TabletSCD330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY330702d9-842c-416d-9b11-b4a9b707e9b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-986-0082804098600100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-00) 2024-05-21NoNoCurrent
82804-986-308280409863030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-30) 2024-05-21NoNoCurrent
82804-986-5582804098655500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-55) 2024-05-21NoNoCurrent
82804-986-608280409866060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-60) 2024-05-21NoNoCurrent
82804-986-6482804098664240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-64) 2024-05-21NoNoCurrent
82804-986-7282804098672120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-72) 2024-05-21NoNoCurrent
82804-986-7882804098678180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-78) 2024-05-21NoNoCurrent
82804-986-908280409869090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-90) 2024-05-21NoNoCurrent