ZAVZPRET

Product NDC: 63539-135
11-digit product format: 635390135
Labeler code: 63539
Product ID: 63539-135_3f4a6bba-ce03-463b-9167-65580312987f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zavegepant
Dosage form: SPRAY
Route: NASAL
Labeler: U.S. Pharmaceuticals
Application: NDA216386
Marketing category: NDA
Marketing start: 2023-06-01
Substance: ZAVEGEPANT HYDROCHLORIDE
Active strength: 10 mg/.1mL
Pharmacologic classes: Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
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
N216386-001	ZAVZPRET	ZAVEGEPANT HYDROCHLORIDE	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2023-03-09

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216386-001	8481546	2034-06-26	U-3555	Drug substance, Drug product	2023-04-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216386-001	NCE	2028-03-09

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	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216386-001	ZAVZPRET	EQ 10MG BASE/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-03-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 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	N216386-001	8481546	2034-06-26	U-3555	Drug substance, Drug product	2023-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216386-001	8481546	2034-06-26	U-3555	Drug substance, Drug product	2023-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216386-001	7314883	2023-12-05	U-3555		2023-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216386-001	7314883	2023-12-05	U-3555		2023-04-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216386-001	7314883	2023-12-05	U-3555		2023-04-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216386-001	8481546	2031-10-07	U-3555	Drug substance, Drug product	2023-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216386-001	7314883	2023-12-05	U-3555		2023-04-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216386-001	7220862	2024-01-21		Drug substance, Drug product	2023-04-06	`a67488948f0b…`

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	N216386-001	NCE	2028-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216386-001	NCE	2028-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216386-001	NCE	2028-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216386-001	NCE	2028-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216386-001	NCE	2028-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216386-001	NCE	2028-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216386-001	NCE	2028-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216386-001	NCE	2028-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216386-001	NCE	2028-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216386-001	NCE	2028-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216386-001	NCE	2028-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216386-001	NCE	2028-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216386-001	NCE	2028-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216386-001	NCE	2028-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216386-001	NCE	2028-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216386-001	NCE	2028-03-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216386-001	NCE	2028-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216386-001	NCE	2028-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216386-001	NCE	2028-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216386-001	NCE	2028-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216386-001	NCE	2028-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216386-001	NCE	2028-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216386-001	NCE	2028-03-09	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216386-001	NCE	2028-03-09	`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: ZAVZPRET
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZAVEGEPANT HYDROCHLORIDE	10 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
000QCM6HAL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2637974	Internal RxNorm lookup
2637980	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
1191475f-e999-49f4-a805-93ad08596b1b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a5952d4-efce-4f1c-ae79-e7329a08a8e7	Product name	1	20231005
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63539-135-01	ZAVZPRET	0.1 mL in 1 VIAL, SINGLE-DOSE	SPRAY	0.1	4
63539-135-01	ZAVZPRET	1 in 1 BLISTER PACK	SPRAY	1	4
63539-135-02	ZAVZPRET	1 in 1 CARTON	SPRAY	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-135	ZAVZPRET (ZAVEGEPANT) SPRAY [U.S. PHARMACEUTICALS]	3	Current NDC, 3 package rows	20250507_1191475f-e999-49f4-a805-93ad08596b1b.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZAVZPRET	ZAVEGEPANT	U.S. Pharmaceuticals	1191475f-e999-49f4-a805-93ad08596b1b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216386 application number: NDA216386 ndc (product): 63539-135
ZAVZPRET	ZAVEGEPANT	Pfizer Laboratories Div Pfizer Inc	9c4a7aec-daef-4961-ba77-92f4b58be780	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216386 application number: NDA216386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2637974	zavegepant 10 MG Nasal Spray	PSN	1191475f-e999-49f4-a805-93ad08596b1b	4
2637980	Zavzpret 10 MG Nasal Spray	PSN	1191475f-e999-49f4-a805-93ad08596b1b	4
2637980	zavegepant 10 MG Nasal Spray [Zavzpret]	SBD	1191475f-e999-49f4-a805-93ad08596b1b	4
2637974	zavegepant 10 MG Nasal Spray	SCD	1191475f-e999-49f4-a805-93ad08596b1b	4
2637980	Zavzpret 10 MG Nasal Spray	SY	1191475f-e999-49f4-a805-93ad08596b1b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63539-135-01	63539013501	0.1 mL in 1 VIAL, SINGLE-DOSE	0.1 ml				Historical
63539-135-02	63539013502	1 BLISTER PACK in 1 CARTON (63539-135-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSE	1 blister pack	2023-06-01	Yes	No	Current