Granisetron hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Natco Pharma Limited

DUNS Number

918588174

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

63850-0005

Application Number

ANDA078969

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 25, 2019

Ingredients

Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT