SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride Tablets USP
Approved
Approval ID
6b532e6a-b040-4a10-a242-fb6d8dfc0852
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-028
Application NumberANDA202825
Product Classification
M
Marketing Category
C73584
G
Generic Name
SERTRALINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SERTRALINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-047
Application NumberANDA202825
Product Classification
M
Marketing Category
C73584
G
Generic Name
SERTRALINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM