Carbidopa-levodopa

Product NDC
72888-108
11-digit product format
728880108
Labeler code
72888
Product ID
72888-108_519a6595-11b5-ab1c-e063-6394a90a0223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd.,
Application
ANDA216505
Marketing category
ANDA
Marketing start
2022-09-21
Substance
CARBIDOPA; 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216505-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21
A216505-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21
A216505-003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216505-001AB
A216505-002AB
A216505-003AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2022-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2022-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216505-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2022-09-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216505-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216505-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216505-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216505-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216505-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216505-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216505-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216505-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216505-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216505-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216505-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216505-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216505-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216505-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216505-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216505-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216505-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216505-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216505-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216505-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa-levodopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 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
MNX7R8C5VOInternal UNII lookup
46627O600JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197443Internal RxNorm lookup
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
9e3c796b-2e68-4bcc-b927-18a58bea4703Available 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
72888-108-00Carbidopa-levodopa1000 in 1 BOTTLETABLET10005
72888-108-01Carbidopa-levodopa100 in 1 BOTTLETABLET1005
72888-108-05Carbidopa-levodopa500 in 1 BOTTLETABLET5005
72888-108-30Carbidopa-levodopa30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-108-00EA - Each72888-10861094fd6-14e6-47f3-af3c-a48415d4960712023-02-06
72888-108-01EA - Each72888-10802074091-9194-47bd-b829-7681ed9a855e12023-02-06
72888-108-05EA - Each72888-10840fee004-380e-4e90-b34e-b4a914504b8b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-108CARBIDOPA-LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET [ADVAGEN PHARMA LTD.,]2Current NDC, Legacy NDC, 4 package rows20230115_9e3c796b-2e68-4bcc-b927-18a58bea4703.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa-levodopaCARBIDOPA AND LEVODOPAAdvagen Pharma Ltd.,9e3c796b-2e68-4bcc-b927-18a58bea47032026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216505
application number: ANDA216505
ndc (product): 72888-108
Carbidopa-levodopaCARBIDOPA AND LEVODOPAAmerican Health Packagingdd2215a9-ee0f-443a-a2e3-3d0578c8cd8f2025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216505
application number: ANDA216505
Carbidopa-levodopaCARBIDOPA AND LEVODOPABryant Ranch Prepackc3f17bad-f486-4529-90df-5fdab3cb1d0b2025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216505
application number: ANDA216505
Carbidopa-levodopaCARBIDOPA AND LEVODOPACoupler LLC2cdca970-f077-3a80-e063-6294a90ab3352025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216505
application number: ANDA216505
Carbidopa-levodopaCARBIDOPA AND LEVODOPATruPharma, LLCd1bb319b-82a3-4b66-9cdc-f77fdb8383ce2023-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216505
application number: ANDA216505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN9e3c796b-2e68-4bcc-b927-18a58bea47035
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN9e3c796b-2e68-4bcc-b927-18a58bea47035
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN9e3c796b-2e68-4bcc-b927-18a58bea47035
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD9e3c796b-2e68-4bcc-b927-18a58bea47035
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD9e3c796b-2e68-4bcc-b927-18a58bea47035
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD9e3c796b-2e68-4bcc-b927-18a58bea47035
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY9e3c796b-2e68-4bcc-b927-18a58bea47035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-108-00728880108001000 TABLET in 1 BOTTLE (72888-108-00) 1000 tablet2023-04-010000-00-00NoNoCurrent
72888-108-0172888010801100 TABLET in 1 BOTTLE (72888-108-01) 100 tablet2023-04-010000-00-00NoNoCurrent
72888-108-0572888010805500 TABLET in 1 BOTTLE (72888-108-05) 500 tablet2023-04-010000-00-00NoNoCurrent
72888-108-307288801083030 TABLET in 1 BOTTLE (72888-108-30) 30 tablet2023-04-010000-00-00NoNoCurrent