Carbidopa and levodopa

Product NDC
0093-9701
11-digit product format
000939701
Labeler code
0093
Product ID
0093-9701_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
10; 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074260-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03
A074260-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03
A074260-003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074260-001AB
A074260-002AB
A074260-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB1993-09-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALABRS1993-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074260-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB1993-09-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074260-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074260-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074260-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074260-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074260-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074260-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074260-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074260-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074260-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074260-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074260-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074260-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074260-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074260-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074260-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074260-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074260-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074260-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074260-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074260-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA HYDRATE10 mg/1
LEVODOPA100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MNX7R8C5VOInternal UNII lookup
46627O600JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197443Internal RxNorm lookup
197444Internal RxNorm lookup
197445Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ace5274-b6cf-414c-b9c0-f60e28a9cea5Available on FDA.report

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
0093-9701-01Carbidopa and levodopa100 in 1 BOTTLETABLET10010
0093-9701-05Carbidopa and levodopa500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-9701-01EA - Each0093-9701b72da441-030d-4fb8-bded-19780eca3cab12022-02-07
0093-9701-05EA - Each0093-97019e64c634-a6b8-49c4-8b08-ff487c2076df12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9701CARBIDOPA AND LEVODOPA TABLET [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20240308_4ace5274-b6cf-414c-b9c0-f60e28a9cea5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and levodopaCARBIDOPA AND LEVODOPATeva Pharmaceuticals USA, Inc.4ace5274-b6cf-414c-b9c0-f60e28a9cea52026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
ndc (product): 0093-9701
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKAREe232e055-7892-3541-e053-2995a90a1e742026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKAREda471cd4-dcee-b026-e053-2a95a90a3d812026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKARE11e706c4-433c-1ea6-e063-6294a90ad3602026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAmerican Health Packaginga62ae74d-6677-459c-b338-00e6851a1e002025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
Carbidopa and levodopaCARBIDOPA AND LEVODOPAA-S Medication Solutions6d8968a1-0317-464a-bd03-4f683f562de22023-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAphena Pharma Solutions - Tennessee, LLC64254508-dbe7-4512-902d-f4a6ef2bfdf82022-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074260
application number: ANDA074260

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
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSNe232e055-7892-3541-e053-2995a90a1e743
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCDe232e055-7892-3541-e053-2995a90a1e743
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSYe232e055-7892-3541-e053-2995a90a1e743
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSYe232e055-7892-3541-e053-2995a90a1e743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-9701-0100093970101100 TABLET in 1 BOTTLE (0093-9701-01) 100 tablet2022-01-180000-00-00NoNoCurrent
0093-9701-0500093970105500 TABLET in 1 BOTTLE (0093-9701-05) 500 tablet2022-06-140000-00-00NoNoCurrent