CARBIDOPA, LEVODOPA AND ENTACAPONE

Product NDC
64679-787
11-digit product format
646790787
Labeler code
64679
Product ID
64679-787_337712b0-f220-4f72-ba81-7ffdcb9643b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa, levodopa and entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
NDA021485
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-02-29
Marketing end
0000-00-00
Substance
LEVODOPA; ENTACAPONE; CARBIDOPA
Active strength
200 mg/1; mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-787-042020-02-21C16284748780-19d75b9d0-bc89-f424-e053-dadaa90a57cebb65f952-284f-46f9-8cfc-4aff59ba5dcd
64679-787-042020-01-31C16284748780-19d75b9d0-bc89-f424-e053-dadaa90a57cebb65f952-284f-46f9-8cfc-4aff59ba5dcd

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-787-02EA - Each64679-787c356a781-e82e-41ae-9d58-4db7ec95f81b12012-07-24
64679-787-04EA - Each64679-787bb5dde47-e2a6-4d6c-b75a-49b9e34f9c3d12014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-787-0464679078704100 TABLET, FILM COATED in 1 BOTTLE (64679-787-04) 2014-04-080000-00-00NoNoCurrent