Carbidopa and Levodopa

Product NDC
55154-0192
11-digit product format
551540192
Labeler code
55154
Product ID
55154-0192_1eaa3310-3185-42fb-83f4-6e44b32f61c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA073607
Marketing category
ANDA
Marketing start
2025-10-10
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
25; 250 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073607-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073607-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-283f01610625f2…
2019-09-15 20:21 UTC2019-09A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073607-001CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB1992-08-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073607-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073607-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073607-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073607-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073607-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073607-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073607-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073607-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073607-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073607-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073607-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073607-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073607-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073607-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073607-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073607-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073607-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073607-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073607-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073607-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073607-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073607-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073607-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073607-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073607-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073607-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073607-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073607-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073607-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073607-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073607-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073607-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073607-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073607-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073607-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073607-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073607-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073607-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073607-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073607-001AB1cb3db0bc1861…

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
LEVODOPA250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
19d853e2-b8bd-490e-b8d2-b38bec68a139Available 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
55154-0192-0Carbidopa and Levodopa10 in 1 BAGTABLET103
55154-0192-0Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET13

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMajor Pharmaceuticals3f6d393e-ac84-4a3c-a837-199d1ec71fd22026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073607
application number: ANDA073607
Carbidopa and LevodopaCARBIDOPA AND LEVODOPADr. Reddy's Laboratories Inc87ab55c9-203d-d595-3e3e-0e38f2f6d9c42026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073607
application number: ANDA073607
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACardinal Health 107, LLC19d853e2-b8bd-490e-b8d2-b38bec68a1392026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073607
application number: ANDA073607
ndc (product): 55154-0192
Carbidopa and LevodopaCARBIDOPA AND LEVODOPANCS HealthCare of KY, LLC dba Vangard Labs45909de3-0852-4e61-8a9e-23f8fcc2463a2024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073607
application number: ANDA073607

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-0192-05515401920010 BLISTER PACK in 1 BAG (55154-0192-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2025-10-10NoNoCurrent