Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
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
63187-483Application Number
ANDA078050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 1, 2018POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
OndansetronActive
Code: 4AF302ESOSClass: ACTIBQuantity: 8 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
Ondansetron
Product Details
NDC Product Code
63187-002Application Number
ANDA078050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 1, 2018ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
OndansetronActive
Code: 4AF302ESOSClass: ACTIBQuantity: 4 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT