Carbidopa

Product NDC
42799-123
11-digit product format
427990123
Labeler code
42799
Product ID
42799-123_462dd421-0006-e25d-e063-6294a90ad0ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA205304
Marketing category
ANDA
Marketing start
2016-02-19
Substance
CARBIDOPA
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42799-12342799-123-02DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A205304-001CARBIDOPACARBIDOPA25MGTABLET / ORALAB2016-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205304-001AB

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 UTC2026-02A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205304-001CARBIDOPA25MGTABLET / ORALAB2016-02-17cb3db0bc1861…

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 UTC2026-02A205304-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205304-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205304-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205304-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205304-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205304-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205304-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205304-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205304-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205304-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205304-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205304-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205304-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205304-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205304-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205304-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205304-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205304-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205304-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205304-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205304-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205304-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205304-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205304-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205304-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205304-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205304-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205304-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205304-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205304-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205304-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205304-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205304-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205304-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205304-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205304-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205304-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205304-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205304-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205304-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260260Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55b99f22-9eb2-4df6-9979-bc4c3af5e454Available 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
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
42799-123-01Carbidopa100 in 1 BOTTLETABLET1008
42799-123-02Carbidopa1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-123-01EA - Each42799-1231619fbc5-3cd2-46d1-a881-c6f4f343d99412016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-123CARBIDOPA TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]6Current NDC, Legacy NDC, 2 package rows20250221_55b99f22-9eb2-4df6-9979-bc4c3af5e454.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbidopaCARBIDOPAEdenbridge Pharmaceuticals LLC.55b99f22-9eb2-4df6-9979-bc4c3af5e4542025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205304
application number: ANDA205304
ndc (product): 42799-123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260260carbidopa 25 MG Oral TabletPSN55b99f22-9eb2-4df6-9979-bc4c3af5e4548
260260carbidopa 25 MG Oral TabletSCD55b99f22-9eb2-4df6-9979-bc4c3af5e4548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-123-0142799012301100 TABLET in 1 BOTTLE (42799-123-01) 100 tablet2016-02-190000-00-00NoNoCurrent
42799-123-02427990123021000 TABLET in 1 BOTTLE (42799-123-02) 1000 tablet2016-02-190000-00-00NoNoCurrent