Carbidopa and Levodopa

Product NDC
0378-0078
11-digit product format
003780078
Labeler code
0378
Product ID
0378-0078_26fe1be4-3d62-438c-a3d3-21999097cbae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090324
Marketing category
ANDA
Marketing start
2011-05-16
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA
Active strength
10 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-0078DDiscontinued by firm2026-10-05
excluded packagepackage0378-00780378-0078-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-0078-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-0078-01f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090324-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA10MG;100MGTABLET / ORAL2009-09-28
A090324-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28
A090324-003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORAL2009-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090324-002AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090324-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090324-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090324-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090324-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090324-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090324-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090324-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090324-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-002AB15c6f7cd8ea54…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0078-01EA - Each0378-0078206cde3c-5970-4bde-9cc0-f5584831d29b12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0078CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSNa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCDa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSYa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSYa7e669fc-c011-4e51-85e6-b68d4e4738a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0078-0100378007801100 TABLET in 1 BOTTLE, PLASTIC (0378-0078-01) 100 tablet2011-05-160000-00-00NoNoCurrent