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Ticlopidine Hydrochloride

TICLOPIDINE HYDROCHLORIDE TABLETS USP 0154 Rx only

Approved
Approval ID

77d619f8-05a3-408a-a6f8-1511694b6a24

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 6, 2016

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ticlopidine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-0079
Application NumberANDA075149
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticlopidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 8, 2009
FDA Product Classification

INGREDIENTS (10)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TICLOPIDINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: A1L4914FMF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Ticlopidine Hydrochloride - FDA Drug Approval Details