FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
31722-381
11-digit product format
317220381
Labeler code
31722
Product ID
31722-381_8027b1c3-6eb7-444b-95a8-8b45f6530a12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218939
Marketing category
ANDA
Marketing start
2025-05-27
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 100 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
A218939-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA10MG;100MGTABLET / ORALAB2025-01-14
A218939-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET / ORALAB2025-01-14
A218939-003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORALAB2025-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218939-001AB
A218939-002AB
A218939-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-14b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2025-01-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2025-01-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2025-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218939-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218939-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218939-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218939-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218939-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218939-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218939-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218939-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218939-003AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218939-003AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
CARBIDOPA AND LEVODOPA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA10 mg/1
LEVODOPA100 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
770ba054-fec4-4833-8096-85c3ce3ae830Available 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
31722-381-01CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET1002
31722-381-05CARBIDOPA AND LEVODOPA500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-381-01EA - Each31722-3812a7acd93-d7d7-4bc3-b3af-acb09a91b39612025-07-08
31722-381-05EA - Each31722-381bbea2244-6b82-4b86-8bef-efbe4583414812025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-381CARBIDOPA AND LEVODOPA TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250528_770ba054-fec4-4833-8096-85c3ce3ae830.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAAphena Pharma Solutions - Tennessee, LLC5644d10f-620e-810e-e063-6294a90af6782026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218939
application number: ANDA218939
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACoupler LLC500f0cdb-10e1-9545-e063-6394a90a3ad12026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218939
application number: ANDA218939
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAXLCare Pharmaceuticals, Inc.0c630a24-dc51-4601-a5d6-2f9e397a04492026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218939
application number: ANDA218939
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACamber Pharmaceuticals, Inc.770ba054-fec4-4833-8096-85c3ce3ae8302026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218939
application number: ANDA218939
ndc (product): 31722-381

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-381-0131722038101100 TABLET in 1 BOTTLE (31722-381-01) 100 tablet2025-05-27NoNoCurrent
31722-381-0531722038105500 TABLET in 1 BOTTLE (31722-381-05) 500 tablet2025-05-27NoNoCurrent