Granisetron Hydrochloride
Granisetron hydrochloride tablets
Approved
Approval ID
65d31bc7-c6a6-4515-8e3a-93e0754540b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2011
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-184
Application NumberANDA078969
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2009
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 318F6L70J8
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT