Keveyis

Product NDC
51672-4177
11-digit product format
516724177
Labeler code
51672
Product ID
51672-4177_f25efe5c-9c1b-47b5-a48f-8d10f775d652
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dichlorphenamide
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., inc.
Application
NDA011366
Marketing category
NDA
Marketing start
2015-08-07
Marketing end
0000-00-00
Substance
DICHLORPHENAMIDE
Active strength
50 mg/1
Pharmacologic classes
Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS],Carbonic Anhydrase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-4177DDiscontinued by firm2026-08-10
excluded packagepackage51672-417751672-4177-1DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-4177-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-4177-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51672-4177-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51672-4177-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51672-4177-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51672-4177-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51672-4177-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51672-4177-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51672-4177-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51672-4177-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51672-4177-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51672-4177-1557ba5c1ecfa…9c80585c8c6e…

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
N011366-001DARANIDEDICHLORPHENAMIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N011366-002KEVEYISDICHLORPHENAMIDE50MGTABLET / ORALABRLD, RS2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N011366-002AB

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 UTC2026-02N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N011366-002KEVEYIS50MGTABLET / ORALABRLD, RS2015-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N011366-001DARANIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N011366-002KEVEYIS50MGTABLET / ORALRLD, RS2015-08-07782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N011366-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011366-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011366-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011366-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011366-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011366-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011366-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011366-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011366-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011366-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011366-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011366-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011366-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N011366-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N011366-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N011366-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N011366-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N011366-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N011366-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N011366-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N011366-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N011366-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N011366-002AB13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N011366-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011366-002ODE-962022-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N011366-002ODE-962022-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N011366-002ODE-962022-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N011366-002ODE-962022-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N011366-002ODE-962022-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N011366-002ODE-962022-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N011366-002ODE-962022-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N011366-002ODE-962022-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N011366-002ODE-962022-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N011366-002ODE-962022-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N011366-002ODE-962022-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09N011366-002ODE-962022-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N011366-002ODE-962022-08-07ea99ee380514…
2023-01-26 05:58 UTC2023-01N011366-002ODE-962022-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N011366-002ODE-962022-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N011366-002ODE-962022-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N011366-002ODE-962022-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N011366-002ODE-962022-08-07cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4177-1EA - Each51672-4177d7ff6752-b81e-4360-978a-cb73f3f7375a12015-10-02

DailyMed Socrata Ingredients#

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
KeveyisDICHLORPHENAMIDEXeris Pharmaceuticals, Inc.d30a87b9-90fb-35b2-e053-2995a90aea2c2026-03-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 011366
application number: NDA011366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4177-151672417701100 TABLET in 1 BOTTLE (51672-4177-1) 100 tablet2015-08-070000-00-00NoNoCurrent