Keveyis
- Product NDC
- 71090-001
- 11-digit product format
- 710900001
- Labeler code
- 71090
- Product ID
- 71090-001_d30a8795-39d4-51c3-e053-2995a90abcf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dichlorphenamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strongbridge US Inc.
- Application
- NDA011366
- Marketing category
- NDA
- Marketing start
- 2015-08-07
- Marketing end
- 2025-10-23
- 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
- 0000-00-00
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71090-001 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 71090-001 | 71090-001-01 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 71090-001 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71090-001 | 71090-001-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011366-001 | DARANIDE | DICHLORPHENAMIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011366-002 | KEVEYIS | DICHLORPHENAMIDE | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011366-002 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | AB | RLD, RS | 2015-08-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N011366-001 | DARANIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N011366-002 | KEVEYIS | 50MG | TABLET / ORAL | RLD, RS | 2015-08-07 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N011366-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011366-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011366-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011366-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011366-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011366-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011366-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011366-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011366-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011366-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011366-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011366-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011366-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011366-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N011366-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N011366-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N011366-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N011366-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N011366-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N011366-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N011366-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N011366-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N011366-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N011366-002 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011366-002 | ODE-96 | 2022-08-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N011366-002 | ODE-96 | 2022-08-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N011366-002 | ODE-96 | 2022-08-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N011366-002 | ODE-96 | 2022-08-07 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N011366-002 | ODE-96 | 2022-08-07 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N011366-002 | ODE-96 | 2022-08-07 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N011366-002 | ODE-96 | 2022-08-07 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N011366-002 | ODE-96 | 2022-08-07 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N011366-002 | ODE-96 | 2022-08-07 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N011366-002 | ODE-96 | 2022-08-07 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N011366-002 | ODE-96 | 2022-08-07 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N011366-002 | ODE-96 | 2022-08-07 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N011366-002 | ODE-96 | 2022-08-07 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | N011366-002 | ODE-96 | 2022-08-07 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N011366-002 | ODE-96 | 2022-08-07 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N011366-002 | ODE-96 | 2022-08-07 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N011366-002 | ODE-96 | 2022-08-07 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011366-002 | ODE-96 | 2022-08-07 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ccb6faba-a46b-40cc-8e13-5fdc58e5b769 | Product name | 2 | 20240208 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71090-001-01 | EA - Each | 71090-001 | b918cc24-3a40-4007-a843-2eb13c5cfeda | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Keveyis | DICHLORPHENAMIDE | Xeris Pharmaceuticals, Inc. | d30a87b9-90fb-35b2-e053-2995a90aea2c | 2026-03-04 | Warnings, Adverse reactions | 011366 NDA011366 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71090-001-01 | 71090000101 | 100 TABLET in 1 BOTTLE (71090-001-01) | 100 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |