Carbidopa and Levodopa

Product NDC
51862-858
11-digit product format
518620858
Labeler code
51862
Product ID
51862-858_b2a61d0f-e190-494b-8016-f0d824d9b3dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA073607
Marketing category
ANDA
Marketing start
2018-07-16
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA
Active strength
25 mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-858-01EA - Each51862-8586c47a301-9b8f-4d4a-9323-7c00a5ddebb712018-11-06
51862-858-05EA - Each51862-8583a3426aa-9027-487d-a24c-b12f83be0ae012019-02-13
51862-858-10EA - Each51862-8586493706f-ec1c-4436-a2ad-b8327895c7e712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-858CARBIDOPA AND LEVODOPA TABLET [MAYNE PHARMA COMMERCIAL LLC]7Legacy NDC20250402_d92bf9c8-ec59-4a7d-996f-2727d6e6adc5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-858-0151862085801100 TABLET in 1 BOTTLE (51862-858-01) 100 tablet2018-07-160000-00-00NoNoCurrent
51862-858-0551862085805500 TABLET in 1 BOTTLE (51862-858-05) 500 tablet2018-07-160000-00-00NoNoCurrent
51862-858-10518620858101000 TABLET in 1 BOTTLE (51862-858-10) 1000 tablet2018-07-160000-00-00NoNoCurrent