Carbidopa and Levodopa (Page 6 of 6)

HOW SUPPLIED

Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg containing 25 mg of carbidopa and 100 mg of levodopa, are dappled-purple in color, oval shaped mottled tablets debossed with “L519” on one side and plain on other side. They are supplied as follows:

NDC 46708-332-30 Bottle of 30 tablets

NDC 46708-332-31 Bottle of 100 tablets

NDC 46708-332-91 Bottle of 1000 tablets

Carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg containing 50 mg of carbidopa and 200 mg of levodopa, are dappled-purple in color, oval shaped mottled tablets debossed with “L520” on one side and plain on other side. They are supplied as follows:

NDC 46708-333-30 Bottle of 30 tablets

NDC 46708-333-31 Bottle of 100 tablets

NDC 46708-333-91 Bottle of 1000 tablets


Storage and Handling

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Alembic Pharmaceuticals Limited
(Formulation Division),
Village Panelav, P. O. Tajpura,
Near Baska, Taluka-Halol,
Panchmahal, Gujarat, India.

Revised: 01/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg/100 mg

NDC 46708-332-30
Carbidopa and Levodopa
Extended-Release
Tablets, USP
25 mg /100 mg
Rx only
30 Tablets
Alembic

30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg/200 mg

NDC 46708-333-30
Carbidopa and Levodopa
Extended-Release
Tablets, USP
50 mg /200 mg
Rx only
30 Tablets
Alembic

30's bottle pack
(click image for full-size original)

CARBIDOPA AND LEVODOPA carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-332
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA (CARBIDOPA ANHYDROUS) CARBIDOPA ANHYDROUS 25 mg
LEVODOPA (LEVODOPA) LEVODOPA 100 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE (dappled-purple) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L519
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-332-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:46708-332-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:46708-332-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210341 06/06/2019
CARBIDOPA AND LEVODOPA carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-333
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA (CARBIDOPA ANHYDROUS) CARBIDOPA ANHYDROUS 50 mg
LEVODOPA (LEVODOPA) LEVODOPA 200 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE (dappled-purple) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code L520
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-333-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:46708-333-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:46708-333-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210341 06/06/2019
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-332), MANUFACTURE (46708-333)

Revised: 06/2019 Alembic Pharmaceuticals Limited

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