Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NCS HealthCare of KY, Inc dba Vangard Labs
NCS HealthCare of KY, Inc dba Vangard Labs
050052943
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glimepiride
Product Details
NDC Product Code
0615-8334Application Number
ANDA091220Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 30, 2020POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 4 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Glimepiride
Product Details
NDC Product Code
0615-8332Application Number
ANDA091220Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 30, 2020GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 1 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Glimepiride
Product Details
NDC Product Code
0615-8333Application Number
ANDA091220Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 30, 2020SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 2 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT