Carbidopa and Levodopa

Product NDC
0378-0085
11-digit product format
003780085
Labeler code
0378
Product ID
0378-0085_26fe1be4-3d62-438c-a3d3-21999097cbae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090324
Marketing category
ANDA
Marketing start
2011-05-16
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA
Active strength
25 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0085-01EA - Each0378-0085123a9f30-a9ec-45ff-86d9-5eda54afa94412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0085CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0085-0100378008501100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01) 100 tablet2011-05-160000-00-00NoNoCurrent