Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sertraline Hydrochloride
Product Details
NDC Product Code
53002-3215Application Number
ANDA077206Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 13, 2023SertralineActive
Code: UTI8907Y6XClass: ACTIMQuantity: 100 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT