Carbidopa and Levodopa

Product NDC
0615-8461
11-digit product format
006158461
Labeler code
0615
Product ID
0615-8461_bd08f206-2051-4ac7-b4ac-b0b83a79029d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA214091
Marketing category
ANDA
Marketing start
2021-10-05
Substance
CARBIDOPA; LEVODOPA
Active strength
50; 200 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 formatDescriptionMarketing startSampleExclude flagStatus
0615-8461-390061584613930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8461-39) 2023-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Extended-Release Tablets, USP Rx onlyNCS HealthCare of KY, LLC dba Vangard Labs2024-09-13HUMAN PRESCRIPTION DRUG LABEL2