Carbidopa and Levodopa

Product NDC
46708-333
11-digit product format
467080333
Labeler code
46708
Product ID
46708-333_a85a56c5-44dd-41d4-ac1c-bdc4758406a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210341
Marketing category
ANDA
Marketing start
2019-06-06
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
46708-333-304670803333030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30) 2019-06-06NoNoHistorical
46708-333-3146708033331100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31) 2019-06-06NoNoHistorical
46708-333-91467080333911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91) 2019-06-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Extended-Release Tablets, USP Rx OnlyAlembic Pharmaceuticals Limited2019-06-06Human Prescription Drug Label1