ZAVZPRET

Product NDC
0069-3500
11-digit product format
000693500
Labeler code
0069
Product ID
0069-3500_d6d7cbe0-0760-4b2b-8323-5b6882832a60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zavegepant
Dosage form
SPRAY
Route
NASAL
Labeler
Pfizer Laboratories Div Pfizer Inc
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216386-001ZAVZPRETZAVEGEPANT HYDROCHLORIDEEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216386-00184815462034-06-26U-3555Drug substance, Drug product2023-04-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216386-001NCE2028-03-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-0984e616aacf4f…
2026-08-18 06:07:402026-07N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N216386-00184815462034-06-26U-3555Drug substance, Drug product2023-04-0684e616aacf4f…
2026-08-18 06:07:402026-07N216386-00184815462034-06-26U-3555Drug substance, Drug product2023-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216386-00172208622024-01-21Drug substance, Drug product2023-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216386-00172208622024-01-21Drug substance, Drug product2023-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216386-00172208622024-01-21Drug substance, Drug product2023-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216386-00172208622024-01-21Drug substance, Drug product2023-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216386-00172208622024-01-21Drug substance, Drug product2023-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216386-00172208622024-01-21Drug substance, Drug product2023-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216386-00172208622024-01-21Drug substance, Drug product2023-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216386-00172208622024-01-21Drug substance, Drug product2023-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216386-00172208622024-01-21Drug substance, Drug product2023-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-068072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216386-00172208622024-01-21Drug substance, Drug product2023-04-066a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216386-00172208622024-01-21Drug substance, Drug product2023-04-061c564ffb4f44…
2024-02-18 07:12 UTC2024-02N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216386-00173148832023-12-05U-35552023-04-06ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N216386-00172208622024-01-21Drug substance, Drug product2023-04-06ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216386-00173148832023-12-05U-35552023-04-06a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216386-00172208622024-01-21Drug substance, Drug product2023-04-06a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216386-00173148832023-12-05U-35552023-04-069b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216386-00172208622024-01-21Drug substance, Drug product2023-04-069b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216386-00184815462031-10-07U-3555Drug substance, Drug product2023-04-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216386-00173148832023-12-05U-35552023-04-06a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216386-00172208622024-01-21Drug substance, Drug product2023-04-06a67488948f0b…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N216386-001NCE2028-03-0984e616aacf4f…
2026-08-18 06:07:402026-07N216386-001NCE2028-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216386-001NCE2028-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216386-001NCE2028-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216386-001NCE2028-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216386-001NCE2028-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216386-001NCE2028-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216386-001NCE2028-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216386-001NCE2028-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216386-001NCE2028-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216386-001NCE2028-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216386-001NCE2028-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216386-001NCE2028-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216386-001NCE2028-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216386-001NCE2028-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216386-001NCE2028-03-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216386-001NCE2028-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216386-001NCE2028-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216386-001NCE2028-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216386-001NCE2028-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216386-001NCE2028-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216386-001NCE2028-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N216386-001NCE2028-03-093f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216386-001NCE2028-03-09a50c72e98297…

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
IngredientStrength
ZAVEGEPANT HYDROCHLORIDE10 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
000QCM6HALInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637974Internal RxNorm lookup
2637980Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c4a7aec-daef-4961-ba77-92f4b58be780Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a5952d4-efce-4f1c-ae79-e7329a08a8e7Product name120231005
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-3500-01ZAVZPRET1 in 1 BLISTER PACKSPRAY17
0069-3500-01ZAVZPRET0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.17
0069-3500-02ZAVZPRET6 in 1 CARTONSPRAY67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-3500-01EA - Each0069-3500117b1be6-a4c8-4332-9dfd-9d4de1af8c5b12023-06-06
0069-3500-02EA - Each0069-3500e157915a-1331-4bf2-9bf0-dcb21342afd612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-3500ZAVZPRET (ZAVEGEPANT) SPRAY [PFIZER LABORATORIES DIV PFIZER INC]6Current NDC, 3 package rows20250418_9c4a7aec-daef-4961-ba77-92f4b58be780.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZAVZPRETZAVEGEPANTU.S. Pharmaceuticals1191475f-e999-49f4-a805-93ad08596b1b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 216386
application number: NDA216386
ZAVZPRETZAVEGEPANTPfizer Laboratories Div Pfizer Inc9c4a7aec-daef-4961-ba77-92f4b58be7802025-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 216386
application number: NDA216386
ndc (product): 0069-3500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637974zavegepant 10 MG Nasal SprayPSN9c4a7aec-daef-4961-ba77-92f4b58be7807
2637980Zavzpret 10 MG Nasal SprayPSN9c4a7aec-daef-4961-ba77-92f4b58be7807
2637980zavegepant 10 MG Nasal Spray [Zavzpret]SBD9c4a7aec-daef-4961-ba77-92f4b58be7807
2637974zavegepant 10 MG Nasal SpraySCD9c4a7aec-daef-4961-ba77-92f4b58be7807
2637980Zavzpret 10 MG Nasal SpraySY9c4a7aec-daef-4961-ba77-92f4b58be7807

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-3500-01000693500011 in 1 BLISTER PACKHistorical
0069-3500-02000693500026 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE6 blister pack2023-06-01NoNoCurrent