SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate
Approved
Approval ID
d2f94500-633e-486e-9c03-2b02266b08e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0586
Application NumberANDA077670
Product Classification
M
Marketing Category
C73584
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (13)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT