FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
50228-461
11-digit product format
502280461
Labeler code
50228
Product ID
50228-461_cea3f5f1-014d-0c1d-e053-2995a90a7f01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA214091
Marketing category
ANDA
Marketing start
2021-10-05
Substance
CARBIDOPA; LEVODOPA
Active strength
50; 200 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA50 mg/1
LEVODOPA200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-461-01Carbidopa and Levodopa100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
50228-461-10Carbidopa and Levodopa1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001
50228-461-30Carbidopa and Levodopa30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-461-01EA - Each50228-4611f361458-22ae-4ca7-a802-263969ea276312022-01-06
50228-461-10EA - Each50228-461075547cb-1555-4ed8-a9a3-ae2cd85a55ab12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-461CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS INC]1Current NDC, Legacy NDC, 3 package rows20211020_1b17ab1e-f3c1-4343-ba28-e2901cd97d43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN3b06a0e2-bec8-4178-942b-67eb47f2916e101
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD3b06a0e2-bec8-4178-942b-67eb47f2916e101
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY3b06a0e2-bec8-4178-942b-67eb47f2916e101
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY3b06a0e2-bec8-4178-942b-67eb47f2916e101
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSNef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSNef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCDef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCDef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-461-0150228046101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-01) 2021-10-050000-00-00NoNoCurrent
50228-461-10502280461101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-10) 2021-10-050000-00-00NoNoCurrent
50228-461-305022804613030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-30) 2021-10-050000-00-00NoNoCurrent