Carbidopa and Levodopa

Product NDC
43353-327
11-digit product format
433530327
Labeler code
43353
Product ID
43353-327_362dfbf2-fc33-4fa7-a407-192aab05c3d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075091
Marketing category
ANDA
Marketing start
2000-04-26
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-327-092023-01-30C16284748780-1f386c649-ec8e-0266-e053-dadaa90a7c1a8dda2a01-637b-4bf6-9c5d-00a77870be02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-327-09Carbidopa and Levodopa9000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-327-09EA - Each43353-3274900c922-bb75-42fb-980d-fbcd35b9815012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-327CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20191221_8dda2a01-637b-4bf6-9c5d-00a77870be02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN8dda2a01-637b-4bf6-9c5d-00a77870be022
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD8dda2a01-637b-4bf6-9c5d-00a77870be022
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY8dda2a01-637b-4bf6-9c5d-00a77870be022
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY8dda2a01-637b-4bf6-9c5d-00a77870be022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-327-09433530327099000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-327-09) 2017-05-160000-00-00NoNoCurrent