Carbidopa and Levodopa (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 25 mg / 100 mg

NDC 71610-647 — Carbidopa and Levodopa, USP 25 mg / 100 mg Tablets — Rx Only

Bottle Label 25 mg / 100 mg
(click image for full-size original)

CARBIDOPA AND LEVODOPA
carbidopa and levodopa tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-647(NDC:50228-458)
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, UNSPECIFIED
STARCH, CORN
CROSPOVIDONE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code SG;458
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-647-60 90 TABLET in 1 BOTTLE None
2 NDC:71610-647-80 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214092 05/07/2021
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-647)

Revised: 05/2022 Aphena Pharma Solutions — Tennessee, LLC

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