Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Coupler Enterprises
Contract Pharmacy Services-PA
945429777
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gemfibrozil
Product Details
NDC Product Code
67046-233Application Number
ANDA077836Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2017SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
GemfibrozilActive
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT