Carbidopa and Levodopa

Product NDC
67046-1614
11-digit product format
670461614
Labeler code
67046
Product ID
67046-1614_43ce4d9e-fb3c-ed29-e063-6294a90a99ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA216537
Marketing category
ANDA
Marketing start
2025-11-17
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 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
67046-1614-36704616140330 TABLET in 1 BLISTER PACK (67046-1614-3) 30 tablet2025-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Tablets, USP R X onlyCoupler LLC2025-11-17HUMAN PRESCRIPTION DRUG LABEL1