Lodosyn

Product NDC
25010-711
11-digit product format
250100711
Labeler code
25010
Product ID
25010-711_7f4ee67e-645e-4fdd-811a-2dc169653684
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa
Dosage form
TABLET
Route
ORAL
Labeler
Bausch Health US, LLC
Application
NDA017830
Marketing category
NDA
Marketing start
2010-04-13
Substance
CARBIDOPA
Active strength
25 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017830-001LODOSYNCARBIDOPA25MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017830-001AB

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 UTC2026-02N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017830-001LODOSYN25MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…

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 UTC2026-02N017830-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017830-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017830-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017830-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017830-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017830-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017830-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017830-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017830-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017830-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017830-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017830-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017830-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017830-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017830-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017830-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017830-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017830-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017830-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017830-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017830-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017830-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017830-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017830-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017830-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017830-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017830-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017830-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017830-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017830-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017830-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017830-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017830-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017830-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017830-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017830-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017830-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017830-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017830-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017830-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lodosyn
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260260Internal RxNorm lookup
261330Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff8e105b-7415-42d4-bbb2-b36cfb8945a5Available 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
25010-711-15Lodosyn100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25010-711-15EA - Each25010-711581365f5-f741-46b6-b3a2-a5229cd0f5c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carbidopaACTIVE INGREDIENTMNX7R8C5VOLODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3
carbidopa anhydrousACTIVE MOIETYKR87B45RGHLODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30LODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MLODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3
starch, cornINACTIVE INGREDIENTO8232NY3SJLODOSYN (CARBIDOPA) TABLET [ATON PHARMA, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25010-711LODOSYN (CARBIDOPA) TABLET [BAUSCH HEALTH US, LLC]10Current NDC, Legacy NDC, 1 package rows20200910_ff8e105b-7415-42d4-bbb2-b36cfb8945a5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbidopaCARBIDOPA TABLETSOceanside Pharmaceuticalsd5204e5e-10ef-4758-8fc6-cb710048c6872020-07-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 017830
application number: NDA017830
LodosynCARBIDOPABausch Health US, LLCff8e105b-7415-42d4-bbb2-b36cfb8945a52020-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 017830
application number: NDA017830
ndc (product): 25010-711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260260carbidopa 25 MG Oral TabletPSNff8e105b-7415-42d4-bbb2-b36cfb8945a510
261330Lodosyn 25 MG Oral TabletPSNff8e105b-7415-42d4-bbb2-b36cfb8945a510
261330carbidopa 25 MG Oral Tablet [Lodosyn]SBDff8e105b-7415-42d4-bbb2-b36cfb8945a510
260260carbidopa 25 MG Oral TabletSCDff8e105b-7415-42d4-bbb2-b36cfb8945a510
261330Lodosyn 25 MG Oral TabletSYff8e105b-7415-42d4-bbb2-b36cfb8945a510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25010-711-1525010071115100 TABLET in 1 BOTTLE (25010-711-15) 100 tablet2010-04-130000-00-00NoNoCurrent