Sertraline
These highlights do not include all the information needed to use sertraline hydrochloride tablets safely and effectively. See full prescribing information for sertraline hydrochloride tablets. SERTRALINE hydrochloride tablets, for oral useInitial U.S. Approval: 1991
Approved
Approval ID
aaffdd32-b857-4070-b597-e29d4738ae59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sertraline
PRODUCT DETAILS
NDC Product Code53217-380
Application NumberANDA077670
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 24, 2018
Generic NameSertraline
INGREDIENTS (11)
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT