Carbidopa and Levodopa

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Aphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

43353-202

Application Number

ANDA090324

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2016

Ingredients

Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1

Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT