Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON
Product Details
NDC Product Code
42254-097Application Number
ANDA077557Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 16, 2009OndansetronActive
Code: 4AF302ESOSClass: ACTIBQuantity: 8 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GLYCERYL DISTEARATEInactive
Code: 73071MW2KMClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ONDANSETRON
Product Details
NDC Product Code
42254-077Application Number
ANDA077557Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 16, 2009OndansetronActive
Code: 4AF302ESOSClass: ACTIBQuantity: 4 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GLYCERYL DISTEARATEInactive
Code: 73071MW2KMClass: IACT