Carbidopa and Levodopa

Product NDC
51079-923
11-digit product format
510790923
Labeler code
51079
Product ID
51079-923_3a39bb13-44d1-2652-e063-6294a90ad211
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075091
Marketing category
ANDA
Marketing start
1999-12-01
Substance
CARBIDOPA; LEVODOPA
Active strength
50; 200 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075091-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30
A075091-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075091-001AB
A075091-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075091-001CARBIDOPA AND LEVODOPA50MG;200MGTABLET, EXTENDED RELEASE / ORALAB1999-09-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075091-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET, EXTENDED RELEASE / ORALAB2000-04-21782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075091-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075091-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075091-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075091-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075091-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075091-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075091-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075091-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075091-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075091-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075091-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075091-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075091-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075091-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075091-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075091-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075091-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075091-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075091-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075091-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075091-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075091-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075091-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075091-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075091-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075091-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075091-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075091-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075091-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075091-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075091-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075091-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075091-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075091-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075091-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075091-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075091-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075091-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075091-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075091-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA50 mg/1
LEVODOPA200 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308988Internal RxNorm lookup
308989Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16f9e4d1-6953-4d4f-b4cf-ad95a856ac25Available 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
51079-923-01Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE113
51079-923-20Carbidopa and Levodopa100 in 1 CARTONTABLET, EXTENDED RELEASE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-923-01EA - Each51079-923fb234cae-5ffe-4513-9f95-476ba73a87b812012-07-24
51079-923-20EA - Each51079-923f56536be-c1f4-4558-b1b0-08efd3e978e912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-923CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]12Current NDC, Legacy NDC, 2 package rows20240104_16f9e4d1-6953-4d4f-b4cf-ad95a856ac25.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Pharmaceuticals Inc.aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075091
application number: ANDA075091
Carbidopa and LevodopaCARBIDOPA AND LEVODOPASafecor Health, LLC015bc056-ee86-4006-ae7c-689b95e566f42026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075091
application number: ANDA075091
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Institutional Inc.16f9e4d1-6953-4d4f-b4cf-ad95a856ac252025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075091
application number: ANDA075091
ndc (product): 51079-923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-923-01510790923011 in 1 BLISTER PACKHistorical
51079-923-2051079092320100 BLISTER PACK in 1 CARTON (51079-923-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-923-01) 100 blister pack1999-12-010000-00-00NoNoCurrent