Granisetron hydrochloride
Approved
Approval ID
d2be8de3-04fe-4e92-82b4-98d749b89596
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2019
Manufacturers
FDA
Natco Pharma Limited
DUNS: 650224736
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granisetron hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0005
Application NumberANDA078969
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2019
FDA Product Classification
INGREDIENTS (9)
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 318F6L70J8
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT