Carbidopa and levodopa

Product NDC
0615-8067
11-digit product format
006158067
Labeler code
0615
Product ID
0615-8067_571e4338-70da-4e3b-88df-5ffeccba1140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA074260
Marketing category
ANDA
Marketing start
2016-07-18
Marketing end
2022-03-31
Substance
CARBIDOPA; LEVODOPA
Active strength
25 mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8067DDiscontinued by firm2026-08-07
excluded packagepackage0615-80670615-8067-05DDiscontinued by firm2026-08-07
excluded packagepackage0615-80670615-8067-39DDiscontinued by firm2026-08-07

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 · 36 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 packagepackage0615-8067-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-8067-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-8067-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-8067-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-8067-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-8067-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-8067-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-8067-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-8067-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-8067-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-8067-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-8067-39cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-8067-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-8067-39302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-8067-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-8067-39ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-8067-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-8067-390efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-8067-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-8067-39ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-8067-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-8067-39367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-8067-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-8067-39557ba5c1ecfa…9c80585c8c6e…

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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8067-050061580670515 TABLET in 1 BLISTER PACK (0615-8067-05) 15 tablet2016-10-052022-03-31NoNoCurrent
0615-8067-390061580673930 TABLET in 1 BLISTER PACK (0615-8067-39) 30 tablet2016-10-052022-03-31NoNoCurrent