Sertraline Hydrochloride
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 use Initial U.S. Approval: 1991
Approved
Approval ID
8e98ee4c-24df-88ce-e053-2a95a90a6713
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4993
Application NumberANDA077206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT