Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LUMIGAN
Product Details
NDC Product Code
54868-6304Application Number
NDA022184Marketing Category
NDA (C73594)Route of Administration
OPHTHALMICEffective Date
September 30, 2011BimatoprostActive
Code: QXS94885MZClass: ACTIBQuantity: 0.1 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sodium phosphate, dibasicInactive
Code: GR686LBA74Class: IACT
benzalkonium chlorideInactive
Code: F5UM2KM3W7Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
LUMIGAN
Product Details
NDC Product Code
54868-4575Application Number
NDA021275Marketing Category
NDA (C73594)Route of Administration
OPHTHALMICEffective Date
September 30, 2011sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
benzalkonium chlorideInactive
Code: F5UM2KM3W7Class: IACT
BimatoprostActive
Code: QXS94885MZClass: ACTIBQuantity: 0.3 mg in 1 mL
sodium phosphate, dibasicInactive
Code: GR686LBA74Class: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT