Carbidopa and levodopa

Product NDC
71610-664
11-digit product format
716100664
Labeler code
71610
Product ID
71610-664_52e6d4be-7d56-484c-871c-4359f7067273
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074260
Marketing category
ANDA
Marketing start
2022-03-15
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MNX7R8C5VOCARBIDOPA38821-49-7CARBIDOPA
46627O600JLEVODOPA59-92-7LEVODOPA

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-664-607161006646090 TABLET in 1 BOTTLE (71610-664-60) 90 tablet2022-10-04NoNoHistorical
71610-664-8071610066480180 TABLET in 1 BOTTLE (71610-664-80) 180 tablet2022-10-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Tablets, USP Rx OnlyAphena Pharma Solutions - Tennessee, LLC2022-10-18HUMAN PRESCRIPTION DRUG LABEL3