FDA.reportPublic FDA data

Sinuva

Product NDC
10599-003
11-digit product format
105990003
Labeler code
10599
Product ID
10599-003_508796b2-418c-402f-a33f-5766a8d4c18b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mometasone furoate
Dosage form
IMPLANT
Route
INTRASINAL
Labeler
Intersect ENT, Inc.
Application
NDA209310
Marketing category
NDA
Marketing start
2018-02-01
Substance
MOMETASONE FUROATE
Active strength
1350 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
N209310-001SINUVAMOMETASONE FUROATE1.35MGIMPLANT / IMPLANTATIONRLD, RS2017-12-08

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209310-00195856812026-04-04U-22722018-04-26
N209310-00175441922026-11-29U-22722018-04-26
N209310-00180256352027-06-12U-2272Drug product2018-04-26
N209310-001103576402031-10-03U-22722019-12-06
N209310-00187632222032-02-08Drug product2018-04-26
N209310-001104063322034-03-13Drug product2019-12-06
N209310-001102321522034-11-24U-2272Drug product2019-12-06

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209310-001SINUVA1.35MGIMPLANT / IMPLANTATIONRLD2017-12-08cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 13 · 487 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209310-00195856812026-04-04U-22722018-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-00175441922026-11-29U-22722018-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-00180256352027-06-12U-2272Drug product2018-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-001103576402031-10-03U-22722019-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-00187632222032-02-08Drug product2018-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-001104063322034-03-13Drug product2019-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209310-001102321522034-11-24U-2272Drug product2019-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-00195856812026-04-04U-22722018-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-00175441922026-11-29U-22722018-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-00180256352027-06-12U-2272Drug product2018-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-001103576402031-10-03U-22722019-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-00187632222032-02-08Drug product2018-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-001104063322034-03-13Drug product2019-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209310-001102321522034-11-24U-2272Drug product2019-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N209310-00195856812026-04-04U-22722018-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-00175441922026-11-29U-22722018-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-00180256352027-06-12U-2272Drug product2018-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-001103576402031-10-03U-22722019-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-00187632222032-02-08Drug product2018-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-001104063322034-03-13Drug product2019-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209310-001102321522034-11-24U-2272Drug product2019-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-00195856812026-04-04U-22722018-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-00175441922026-11-29U-22722018-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-00180256352027-06-12U-2272Drug product2018-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-001103576402031-10-03U-22722019-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-00187632222032-02-08Drug product2018-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-001104063322034-03-13Drug product2019-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209310-001102321522034-11-24U-2272Drug product2019-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-00195856812026-04-04U-22722018-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-00175441922026-11-29U-22722018-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-00180256352027-06-12U-2272Drug product2018-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-001103576402031-10-03U-22722019-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-00187632222032-02-08Drug product2018-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-001104063322034-03-13Drug product2019-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209310-001102321522034-11-24U-2272Drug product2019-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-00176621412024-03-12U-22722018-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-00177132552024-03-12U-22722018-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-00179511302024-03-12U-22722018-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-00179511312024-03-12U-22722018-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209310-00179511332024-03-12U-22722018-04-2603ed91905a0d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209310-001NP2020-12-0874a2ff9319b5…
2020-12-22 03:56 UTC2020-12N209310-001NP2020-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209310-001NP2020-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209310-001NP2020-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09N209310-001NP2020-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N209310-001NP2020-12-08ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1350 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04201GDN4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1995983Internal RxNorm lookup
1995988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e33c1b23-cdc6-4f64-94ba-24b0b42c09bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10599-003-01Sinuva1 in 1 POUCHIMPLANT13
10599-003-01Sinuva1 in 1 CARTONIMPLANT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10599-003-01EA - Each10599-003533536c6-e648-4c06-a51e-cbc0ac68c99f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10599-003SINUVA (MOMETASONE FUROATE) IMPLANT [INTERSECT ENT, INC.]3Current NDC, Legacy NDC, 2 package rows20230127_e33c1b23-cdc6-4f64-94ba-24b0b42c09bf.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SinuvaMOMETASONE FUROATEIntersect ENT, Inc.e33c1b23-cdc6-4f64-94ba-24b0b42c09bf2023-01-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 209310
application number: NDA209310
ndc (product): 10599-003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995983mometasone furoate 1350 MCG Sinus Drug ImplantPSNe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995988SINUVA 1350 MCG Sinus Drug ImplantPSNe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995988mometasone furoate 1.35 MG Drug Implant [Sinuva]SBDe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995983mometasone furoate 1.35 MG Drug ImplantSCDe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995983mometasone furoate 1350 MCG Drug ImplantSYe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995988Sinuva 1.35 MG Drug ImplantSYe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3
1995988Sinuva 1350 MCG Drug ImplantSYe33c1b23-cdc6-4f64-94ba-24b0b42c09bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10599-003-01105990003011 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH1 pouch2018-02-010000-00-00NoNoCurrent