Carbidopa and levodopa tablet, extended release

Ingredients and appearance - Product information

Carbidopa and levodopa tablet, extended release- Carbidopa and levodopa

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-4569
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Carbidopa ( UNII: MNX7R8C5VO)( Carbidopa anhydrous - UNII: KR87B45RGH ) 25 mgin 1
Levodopa ( UNII: 46627O600J)( Levodopa - UNII: 46627O600J ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Hydroxypropyl cellulose (type h) ( UNII: RFW2ET671P)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color PURPLE Imprint Code MYLAN;88
Score 1 Shape OVAL
Size 10 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075091 USA

Carbidopa and levodopa tablet, extended release- Carbidopa and levodopa

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-4568
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Carbidopa ( UNII: MNX7R8C5VO)( Carbidopa anhydrous - UNII: KR87B45RGH ) 50 mgin 1
Levodopa ( UNII: 46627O600J)( Levodopa - UNII: 46627O600J ) 200 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Hydroxypropyl cellulose (type h) ( UNII: RFW2ET671P)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color PURPLE Imprint Code MYLAN;9;4
Score 1 Shape OVAL
Size 13 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075091 USA

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK( 0615-4569, 0615-4568)
This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa.
For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION: Initial Dosage: Patients Currently Treated with Conventional Carbidopa and Levodopa Preparations.