Ondansetron
Ondansetron Orally Disintegrating Tablets, USP
Approved
Approval ID
bf2b41aa-8bac-4de7-98b2-884cbcee6c6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-483
Application NumberANDA078050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (10)
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
ONDANSETRONActive
Quantity: 8 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-002
Application NumberANDA078050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (10)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT