ZELSUVMI

Product NDC: 83787-103
11-digit product format: 837870103
Labeler code: 83787
Product ID: 83787-103_0af12ae7-bb37-4319-94d1-8074b39d4e1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: berdazimer
Dosage form: KIT
Labeler: LNHC, Inc.
Application: NDA217424
Marketing category: NDA
Marketing start: 2025-04-04
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217424-001	ZELSUVMI	BERDAZIMER SODIUM	EQ 10.3% BASE	GEL / TOPICAL		RLD, RS	2024-01-05

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217424-001	8282967	2026-05-30		Drug substance	2024-02-02
N217424-001	8956658	2026-05-30		Drug substance	2024-02-02
N217424-001	10376538	2030-08-20		Drug product	2024-02-02
N217424-001	9737561	2030-08-20	U-3802		2024-02-02
N217424-001	9526738	2031-09-03		Drug product	2024-02-02
N217424-001	10265334	2032-07-03		Drug product	2024-02-02
N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02
N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02
N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02
N217424-001	11285098	2034-02-28		Drug product	2024-02-02
N217424-001	10258564	2034-11-22	U-3797		2024-02-02
N217424-001	10258564	2034-11-22	U-3798		2024-02-02
N217424-001	10258564	2034-11-22	U-3799		2024-02-02
N217424-001	10322081	2035-07-10	U-3793		2024-02-02
N217424-001	10322081	2035-07-10	U-3794		2024-02-02
N217424-001	10322081	2035-07-10	U-3795		2024-02-02
N217424-001	10322081	2035-07-10	U-3796		2024-02-02
N217424-001	10736839	2035-07-10	U-3790		2024-02-02
N217424-001	10736839	2035-07-10	U-3791		2024-02-02
N217424-001	10736839	2035-07-10	U-3792		2024-02-02
N217424-001	11040006	2035-07-10	U-3789	Drug product	2024-02-02
N217424-001	11723858	2035-07-10	U-3788	Drug product	2024-02-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217424-001	NCE	2029-01-05

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 402 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217424-001	8282967	2026-05-30		Drug substance	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	8956658	2026-05-30		Drug substance	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10376538	2030-08-20		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9737561	2030-08-20	U-3802		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9526738	2031-09-03		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10265334	2032-07-03		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11285098	2034-02-28		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3797		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3798		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3799		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3793		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3794		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3795		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3796		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3790		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3791		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3792		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11040006	2035-07-10	U-3789	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11723858	2035-07-10	U-3788	Drug product	2024-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	8282967	2026-05-30		Drug substance	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	8956658	2026-05-30		Drug substance	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10376538	2030-08-20		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9737561	2030-08-20	U-3802		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9526738	2031-09-03		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10265334	2032-07-03		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	11285098	2034-02-28		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3797		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3798		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3799		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3793		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3794		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3795		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3796		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10736839	2035-07-10	U-3790		2024-02-02	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217424-001	NCE	2029-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	NCE	2029-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217424-001	NCE	2029-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217424-001	NCE	2029-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217424-001	NCE	2029-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217424-001	NCE	2029-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217424-001	NCE	2029-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217424-001	NCE	2029-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217424-001	NCE	2029-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217424-001	NCE	2029-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217424-001	NCE	2029-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217424-001	NCE	2029-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217424-001	NCE	2029-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217424-001	NCE	2029-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217424-001	NCE	2029-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217424-001	NCE	2029-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217424-001	NCE	2029-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217424-001	NCE	2029-01-05	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217424-001	NCE	2029-01-05	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2710438	Internal RxNorm lookup
2710443	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
76b17622-bdb9-41ea-b962-c2acc0df71f7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83787-103-31	ZELSUVMI	1 in 1 KIT	KIT	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83787-103-31	GM - Gram	83787-103	ee858aba-b11e-4c6d-8e04-919999afa071	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83787-103	ZELSUVMI (BERDAZIMER) KIT [LNHC, INC.]	2	Current NDC, 1 package rows	20250406_76b17622-bdb9-41ea-b962-c2acc0df71f7.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
ZELSUVMI	BERDAZIMER	LNHC, Inc.	76b17622-bdb9-41ea-b962-c2acc0df71f7	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217424 application number: NDA217424 ndc (product): 83787-103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2710438	berdazimer 10.3 % Topical Gel	PSN	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710443	Zelsuvmi 10.3 % Topical Gel	PSN	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710443	berdazimer 0.103 MG/MG Topical Gel [Zelsuvmi]	SBD	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710438	berdazimer 0.103 MG/MG Topical Gel	SCD	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710438	berdazimer 10.3 % Topical Gel	SY	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710443	Zelsuvmi 0.103 MG/MG Topical Gel	SY	76b17622-bdb9-41ea-b962-c2acc0df71f7	3
2710443	Zelsuvmi 10.3 % Topical Gel	SY	76b17622-bdb9-41ea-b962-c2acc0df71f7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83787-103-31	83787010331	1 KIT in 1 KIT (83787-103-31) * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE (83787-113-14)	1 kit	2025-04-04	No	No	Current