Keveyis

Product NDC: 72065-001
11-digit product format: 720650001
Labeler code: 72065
Product ID: 72065-001_1a581a6b-8813-42ed-8892-21c2341b62c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dichlorphenamide
Dosage form: TABLET
Route: ORAL
Labeler: Xeris Pharmaceuticals, Inc.
Application: NDA011366
Marketing category: NDA
Marketing start: 2021-12-13
Substance: DICHLORPHENAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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N011366-001	DARANIDE	DICHLORPHENAMIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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#

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

Application-product, TE code table
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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N011366-001	DARANIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011366-002	KEVEYIS	50MG	TABLET / ORAL	AB	RLD, RS	2015-08-07	`caaa826d4ba7…`
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UTC	2026-02	N011366-001	DARANIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N011366-002	AB	1	`caaa826d4ba7…`
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 table
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Keveyis
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICHLORPHENAMIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VVJ6673MHY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197594	Internal RxNorm lookup
1661799	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d30a87b9-90fb-35b2-e053-2995a90aea2c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ccb6faba-a46b-40cc-8e13-5fdc58e5b769	Product name	2	20240208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72065-001-01	Keveyis	100 in 1 BOTTLE	TABLET	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72065-001-01	EA - Each	72065-001	fa931eea-d252-40f4-be21-af5d38f969b3	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72065-001	KEVEYIS (DICHLORPHENAMIDE) TABLET [XERIS PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250130_d30a87b9-90fb-35b2-e053-2995a90aea2c.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
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	Exact identifier application applno (NDA): 011366 application number: NDA011366 ndc (product): 72065-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VVJ6673MHY	DICHLORPHENAMIDE	120-97-8	DICHLORPHENAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197594	dichlorphenamide 50 MG Oral Tablet	PSN	d30a87b9-90fb-35b2-e053-2995a90aea2c	9
1661799	Keveyis 50 MG Oral Tablet	PSN	d30a87b9-90fb-35b2-e053-2995a90aea2c	9
1661799	dichlorphenamide 50 MG Oral Tablet [Keveyis]	SBD	d30a87b9-90fb-35b2-e053-2995a90aea2c	9
197594	dichlorphenamide 50 MG Oral Tablet	SCD	d30a87b9-90fb-35b2-e053-2995a90aea2c	9
1661799	Keveyis 50 MG Oral Tablet	SY	d30a87b9-90fb-35b2-e053-2995a90aea2c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72065-001-01	72065000101	100 TABLET in 1 BOTTLE (72065-001-01)	100 tablet	2021-12-13	0000-00-00	No	No	Current