Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acarbose
Product Details
NDC Product Code
0054-0140Application Number
ANDA078470Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 1, 2021AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Acarbose
Product Details
NDC Product Code
0054-0141Application Number
ANDA078470Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 1, 2021AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Acarbose
Product Details
NDC Product Code
0054-0142Application Number
ANDA078470Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 1, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 100 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT