NIRAVAM
NIRAVAM (alprazolam orally disintegrating tablets)
Approved
Approval ID
b19c23b3-d88d-41c3-bea2-789f0898aa86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALPRAZOLAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-938
Application NumberNDA021726
Product Classification
M
Marketing Category
C73594
G
Generic Name
ALPRAZOLAM
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2011
FDA Product Classification
INGREDIENTS (10)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT