NDC Code(s) : 51079-978-01, 51079-978-20, 51079-923-01, 51079-923-20
Packager : Mylan Institutional Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Carbidopa and Levodopacarbidopa and levodopa TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-978(NDC:0378-0088)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA(UNII: MNX7R8C5VO)
(CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) 		CARBIDOPA ANHYDROUS25 mg
LEVODOPA(UNII: 46627O600J)
(LEVODOPA - UNII:46627O600J) 		LEVODOPA100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color purple Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code MYLAN;88
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-978-20100 in 1 CARTON 02/01/2002
1NDC:51079-978-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075091 02/01/2002
Carbidopa and Levodopacarbidopa and levodopa TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-923(NDC:0378-0094)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA(UNII: MNX7R8C5VO)
(CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) 		CARBIDOPA ANHYDROUS50 mg
LEVODOPA(UNII: 46627O600J)
(LEVODOPA - UNII:46627O600J) 		LEVODOPA200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color purple Score 2 pieces
Shape OVAL Size 13 mm
Flavor Imprint Code MYLAN;9;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-923-20100 in 1 CARTON 12/01/1999
1NDC:51079-923-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075091 12/01/1999

LABELER - Mylan Institutional Inc.(039615992)

PRINCIPAL DISPLAY PANEL

NDC 51079-978-20

Carbidopa
and Levodopa
Extended-Release
Tablets, USP
25 mg/
100 mg

100 Tablets (10 x 10)

Each tablet contains:
Carbidopa, USP              25 mg*
*(Anhydrous equivalent)
Levodopa, USP              100 mg

Usual Adult Dosage:See
accompanying prescribing information.

Tablets should be swallowed without
chewing or crushing.

Storage and Handling: Store at 20° to 25°C
(68° to77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in Australia

Rx only

S-12771

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Carbidopa and Levodopa Etended-Release 25 mg/100 mg Tablets Unit Carton LabelCarbidopa and Levodopa Etended-Release 25 mg/100 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

NDC 51079-923-20

Carbidopa
and Levodopa
Extended-Release
Tablets, USP
50 mg/
200 mg

100 Tablets (10 x 10)

Each tablet contains:
Carbidopa, USP             50 mg*
*(Anhydrous equivalent)
Levodopa, USP             200 mg

Usual Adult Dosage:See
accompanying prescribing information.

Tablets should be swallowed without
chewing or crushing.

Storage and Handling: Store at 20° to 25°C
(68° to77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in Australia

Rx only

S-12772

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Carbidopa and Levodopa Extended-Release 50 mg/200 mg Tablets Unit Carton LabelCarbidopa and Levodopa Extended-Release 50 mg/200 mg Tablets Unit Carton Label