Carbidopa and levodopa tablet

Packaging information

American Health Packaging unit dose blisters (see How Suppliedsection) contain drug product from Actavis Parma, Inc. as follows:

(25 mg/100 mg / 100 UD) NDC 68084-093-01 packaged from NDC 0228-2539
(25 mg/250 mg / 100 UD) NDC 68084-094-01 packaged from NDC 0228-2540

Distributed by:
American Health Packaging
Columbus, OH 43217
8009201/1016

Ingredients and appearance - Product information

Carbidopa and levodopa tablet- Carbidopa and levodopa

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-093
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
Starch, corn ( UNII: O8232NY3SJ)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)

Product Characteristics

Color yellow (mottled) Size 9 mm
Shape ROUND Score 2
Imprint Code R;539

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074260 USA

Carbidopa and levodopa tablet- Carbidopa and levodopa

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-094
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 ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)

Product Characteristics

Color blue (light blue, mottled) Size 10 mm
Shape ROUND Score 2
Imprint Code R;540

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074260 USA

Labeler - American Health Packaging( 929561009)

Establishment

Name ID/FEI Business Operations
American Health Packaging 929561009 repack( 68084-093, 68084-094)

Package/label display panel blister - 25 mg/100 mg

Carbidopa and Levodopa
Tablet, USP
25 mg/100 mg

Package/label display panel carton - 25 mg/250 mg

NDC 68084- 094-01

Carbidopa
and Levodopa

Tablets, USP
25 mg/250 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Carbidopa, USP .................................................................. 25 mg*
*(Anhydrous equivalent)
Levodopa, USP....................................................................250 mg

Usual Adult Dosage:See package insert for full prescribing
information.

Storeat 20 to 25C (68 to 77F); excursions permitted
between 15 to 30C (59 to 86F) [see USP Controlled Room
Temperature]. Protect from light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION:Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 0228-2540, Actavis Pharma, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

093338
0209401/0119

Package/label display panel blister - 25 mg/250 mg

Carbidopa and Levodopa
Tablet, USP
25 mg/250 mg