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
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
71205-856Application Number
ANDA091343Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2022AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ACARBOSE
Product Details
NDC Product Code
71205-855Application Number
ANDA091343Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2022MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 50 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ACARBOSE
Product Details
NDC Product Code
71205-854Application Number
ANDA091343Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2022AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT