ZOLOFT
ZOLOFT (sertraline hydrochloride)Tablets and Oral Concentrate
Approved
Approval ID
c3b0b1f8-abfd-4054-8645-fd076305f4f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 2
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 Code16590-251
Application NumberNDA019839
Product Classification
M
Marketing Category
C73594
G
Generic Name
SERTRALINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2010
FDA Product Classification
INGREDIENTS (10)
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIB
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
dibasic calcium phosphate dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
SERTRALINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-250
Application NumberNDA019839
Product Classification
M
Marketing Category
C73594
G
Generic Name
SERTRALINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2010
FDA Product Classification
INGREDIENTS (11)
dibasic calcium phosphate dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIB
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT