Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carlsbad Technology, Inc.
Carlsbad Technology, Inc.
968263561
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
61442-117Application Number
ANDA077911Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 27, 2022POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 4 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Glimepiride
Product Details
NDC Product Code
61442-116Application Number
ANDA077911Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 27, 2022LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 2 mg in 1 1
Glimepiride
Product Details
NDC Product Code
61442-115Application Number
ANDA077911Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 27, 2022CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 1 mg in 1 1
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT