FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0378-0085
11-digit product format
003780085
Labeler code
0378
Product ID
0378-0085_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
25 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 productproduct0378-0085DDiscontinued by firm2026-10-15
excluded packagepackage0378-00850378-0085-01DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-28c2088c7a36db…
2026-10-15 13:18:302026-09A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28c2088c7a36db…
2026-10-15 13:18:302026-09A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-28c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 118 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090324-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090324-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090324-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090324-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090324-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090324-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090324-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090324-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090324-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090324-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090324-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090324-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090324-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090324-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090324-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090324-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090324-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090324-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090324-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090324-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090324-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090324-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090324-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090324-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090324-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090324-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090324-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090324-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090324-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090324-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090324-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090324-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090324-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090324-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090324-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090324-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090324-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090324-002AB16a51e52b5d6a…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0085-01EA - Each0378-0085123a9f30-a9ec-45ff-86d9-5eda54afa94412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0085CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0085-0100378008501100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01) 100 tablet2011-05-160000-00-00NoNoCurrent