FDA.reportPublic FDA data

Carbidopa and levodopa

Product NDC
0093-9703
11-digit product format
000939703
Labeler code
0093
Product ID
0093-9703_72ae34b7-ce54-43cf-9950-226ef002f7bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074260
Marketing category
ANDA
Marketing start
2023-12-15
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
25; 250 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
CARBIDOPA HYDRATE25 mg/1
LEVODOPA250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui197443, 197444, 197445

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
0093-9703-01Carbidopa and levodopa100 in 1 BOTTLETABLET10010
0093-9703-05Carbidopa and levodopa500 in 1 BOTTLETABLET50010
0093-9703-10Carbidopa and levodopa1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9703CARBIDOPA AND LEVODOPA TABLET [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, 3 package rows20240308_4ace5274-b6cf-414c-b9c0-f60e28a9cea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY4ace5274-b6cf-414c-b9c0-f60e28a9cea510
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNa62ae74d-6677-459c-b338-00e6851a1e004
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSNa62ae74d-6677-459c-b338-00e6851a1e004
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDa62ae74d-6677-459c-b338-00e6851a1e004
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCDa62ae74d-6677-459c-b338-00e6851a1e004
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYa62ae74d-6677-459c-b338-00e6851a1e004
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSYa62ae74d-6677-459c-b338-00e6851a1e004
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYa62ae74d-6677-459c-b338-00e6851a1e004
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSYa62ae74d-6677-459c-b338-00e6851a1e004
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN11e706c4-433c-1ea6-e063-6294a90ad3602
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD11e706c4-433c-1ea6-e063-6294a90ad3602
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY11e706c4-433c-1ea6-e063-6294a90ad3602
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY11e706c4-433c-1ea6-e063-6294a90ad3602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0093-9703-0100093970301100 TABLET in 1 BOTTLE (0093-9703-01) 100 tablet2024-03-05NoNoCurrent
0093-9703-0500093970305500 TABLET in 1 BOTTLE (0093-9703-05) 500 tablet2023-12-15NoNoCurrent
0093-9703-10000939703101000 TABLET in 1 BOTTLE (0093-9703-10) 1000 tablet2024-02-08NoNoCurrent