Carbidopa-levodopa

Product NDC
67046-1507
11-digit product format
670461507
Labeler code
67046
Product ID
67046-1507_2cdcb5e6-b724-c955-e063-6294a90af382
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA216505
Marketing category
ANDA
Marketing start
2025-01-29
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
67046-1507-36704615070330 TABLET in 1 BLISTER PACK (67046-1507-3) 30 tablet2025-01-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Tablets, USPCoupler LLC2025-01-29HUMAN PRESCRIPTION DRUG LABEL1