FDA.reportPublic FDA data

Carbidopa and levodopa

Product NDC
0093-9702
11-digit product format
000939702
Labeler code
0093
Product ID
0093-9702_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
2022-01-18
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
25; 100 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
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
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
0093-9702-01Carbidopa and levodopa100 in 1 BOTTLETABLET10010
0093-9702-05Carbidopa and levodopa500 in 1 BOTTLETABLET50010
0093-9702-10Carbidopa and levodopa1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-9702-01EA - Each0093-9702016d8ebd-5603-42f3-a97d-e9ca8194ea3512022-03-09
0093-9702-05EA - Each0093-97025d355d9a-c04a-472c-b125-5b05b577e41112022-04-06
0093-9702-10EA - Each0093-9702d0d1b3fb-7359-4033-ab3f-0a7d84444d8012022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9702CARBIDOPA AND LEVODOPA TABLET [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy 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
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNda471cd4-dcee-b026-e053-2a95a90a3d813
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDda471cd4-dcee-b026-e053-2a95a90a3d813
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYda471cd4-dcee-b026-e053-2a95a90a3d813
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYda471cd4-dcee-b026-e053-2a95a90a3d813
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN6d8968a1-0317-464a-bd03-4f683f562de21
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD6d8968a1-0317-464a-bd03-4f683f562de21
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY6d8968a1-0317-464a-bd03-4f683f562de21
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY6d8968a1-0317-464a-bd03-4f683f562de21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-9702-0100093970201100 TABLET in 1 BOTTLE (0093-9702-01) 100 tablet2022-02-250000-00-00NoNoCurrent
0093-9702-0500093970205500 TABLET in 1 BOTTLE (0093-9702-05) 500 tablet2022-03-240000-00-00NoNoCurrent
0093-9702-10000939702101000 TABLET in 1 BOTTLE (0093-9702-10) 1000 tablet2022-01-180000-00-00NoNoCurrent