FDA.reportPublic FDA data

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 1.

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
2026-08-01 22:54:322026-06N216386-001ZAVZPRETEQ 10MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2023-03-09a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N216386-00184815462034-06-26U-3555Drug substance, Drug product2023-04-06a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N216386-001NCE2028-03-09a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 63539-135
ZAVZPRETZAVEGEPANTPfizer Laboratories Div Pfizer Inc9c4a7aec-daef-4961-ba77-92f4b58be7802025-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 216386
application number: NDA216386

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
1191475f-e999-49f4-a805-93ad08596b1bAvailable 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
63539-135-01ZAVZPRET0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.14
63539-135-01ZAVZPRET1 in 1 BLISTER PACKSPRAY14
63539-135-02ZAVZPRET1 in 1 CARTONSPRAY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-135ZAVZPRET (ZAVEGEPANT) SPRAY [U.S. PHARMACEUTICALS]3Current NDC, 3 package rows20250507_1191475f-e999-49f4-a805-93ad08596b1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637974zavegepant 10 MG Nasal SprayPSN1191475f-e999-49f4-a805-93ad08596b1b4
2637980Zavzpret 10 MG Nasal SprayPSN1191475f-e999-49f4-a805-93ad08596b1b4
2637980zavegepant 10 MG Nasal Spray [Zavzpret]SBD1191475f-e999-49f4-a805-93ad08596b1b4
2637974zavegepant 10 MG Nasal SpraySCD1191475f-e999-49f4-a805-93ad08596b1b4
2637980Zavzpret 10 MG Nasal SpraySY1191475f-e999-49f4-a805-93ad08596b1b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63539-135-01635390135010.1 mL in 1 VIAL, SINGLE-DOSE0.1 mlHistorical
63539-135-02635390135021 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-DOSE1 blister pack2023-06-01YesNoCurrent