Carbidopa and Levodopa

Product NDC
0904-7549
11-digit product format
009047549
Labeler code
0904
Product ID
0904-7549_f5d5ad01-a099-46cd-95fc-98ebc80ddc96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA073607
Marketing category
ANDA
Marketing start
2025-04-28
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 250 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
0904-7549-6100904754961100 BLISTER PACK in 1 CARTON (0904-7549-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2025-04-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CARBIDOPA AND LEVODOPA TABLETS, USPCardinal Health 107, LLC2026-04-16HUMAN PRESCRIPTION DRUG LABEL3
CARBIDOPA AND LEVODOPA TABLETS, USPMajor Pharmaceuticals2025-04-28HUMAN PRESCRIPTION DRUG LABEL2
CARBIDOPA AND LEVODOPA TABLETS, USPCardinal Health 107, LLC2025-02-24HUMAN PRESCRIPTION DRUG LABEL1