Carbidopa and Levodopa

Product NDC
0378-5053
11-digit product format
003785053
Labeler code
0378
Product ID
0378-5053_c9f6ebac-312d-4f8f-b19c-c9f12e97588f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078893
Marketing category
ANDA
Marketing start
2008-09-18
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5053-01EA - Each0378-505348aa30aa-740f-4340-9f1b-c84f6fb5526e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-5053-0100378505301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5053-01) 2008-09-180000-00-00NoNoCurrent