Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceutical, Inc.
NuCare Pharmaceuticals, Inc.
010632300
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
66267-436Application Number
ANDA077836Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 11, 2021CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
GemfibrozilActive
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1