Products2
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
68645-572Application Number
ANDA077091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 2 mg in 1 1
Glimepiride
Product Details
NDC Product Code
68645-573Application Number
ANDA077091Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2023POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 4 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT