Noctiva

Product NDC
71758-106
11-digit product format
717580106
Labeler code
71758
Product ID
71758-106_1e919787-67b7-4b45-9274-0ddbe6a8b674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desmopressin acetate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Avadel Specialty Pharmaceuticals, LLC
Application
NDA201656
Marketing category
NDA
Marketing start
2017-12-08
Marketing end
2020-06-30
Substance
DESMOPRESSIN ACETATE
Active strength
1 ug/1
Pharmacologic classes
Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71758-106DDiscontinued by firm2026-10-20
excluded packagepackage71758-10671758-106-55DDiscontinued by firm2026-10-20
excluded packagepackage71758-10671758-106-56DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71758-106-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71758-106-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71758-106-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71758-106-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71758-106-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71758-106-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71758-106-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71758-106-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71758-106-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71758-106-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71758-106-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71758-106-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71758-106-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71758-106-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71758-106-55ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71758-106-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71758-106-550efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71758-106-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71758-106-55ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71758-106-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71758-106-55367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71758-106-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71758-106-55557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71758-106-56557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201656-001NOCTIVADESMOPRESSIN ACETATE0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03
N201656-002NOCTIVADESMOPRESSIN ACETATE0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201656-001114199142030-06-15U-34312022-09-20
N201656-001120901902030-06-15U-4003Drug product2024-10-11
N201656-00195393022030-06-15Drug product2017-03-31
N201656-002114199142030-06-15U-34312022-09-20
N201656-002120901902030-06-15U-4003Drug product2024-10-11
N201656-00295393022030-06-15Drug product2017-03-31

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03c2088c7a36db…
2026-10-15 13:18:302026-09N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03c2088c7a36db…
2026-09-14 22:38:342026-08N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0384e616aacf4f…
2026-08-18 06:07:402026-07N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201656-001NOCTIVA0.00083MG/SPRAYSPRAY, METERED / NASALRLD2017-03-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201656-002NOCTIVA0.00166MG/SPRAYSPRAY, METERED / NASALRLD2017-03-034b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 1 of 7 · 257 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N201656-001114199142030-06-15U-34312022-09-20c2088c7a36db…
2026-10-15 13:18:302026-09N201656-001120901902030-06-15U-4003Drug product2024-10-11c2088c7a36db…
2026-10-15 13:18:302026-09N201656-00195393022030-06-15Drug product2017-03-31c2088c7a36db…
2026-10-15 13:18:302026-09N201656-002114199142030-06-15U-34312022-09-20c2088c7a36db…
2026-10-15 13:18:302026-09N201656-002120901902030-06-15U-4003Drug product2024-10-11c2088c7a36db…
2026-10-15 13:18:302026-09N201656-00295393022030-06-15Drug product2017-03-31c2088c7a36db…
2026-09-14 22:38:342026-08N201656-001114199142030-06-15U-34312022-09-2084e616aacf4f…
2026-09-14 22:38:342026-08N201656-001120901902030-06-15U-4003Drug product2024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N201656-00195393022030-06-15Drug product2017-03-3184e616aacf4f…
2026-09-14 22:38:342026-08N201656-002114199142030-06-15U-34312022-09-2084e616aacf4f…
2026-09-14 22:38:342026-08N201656-002120901902030-06-15U-4003Drug product2024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N201656-00295393022030-06-15Drug product2017-03-3184e616aacf4f…
2026-08-18 06:07:402026-07N201656-001114199142030-06-15U-34312022-09-20caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-001120901902030-06-15U-4003Drug product2024-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-00195393022030-06-15Drug product2017-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-002114199142030-06-15U-34312022-09-20caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-002120901902030-06-15U-4003Drug product2024-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N201656-00295393022030-06-15Drug product2017-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201656-001114199142030-06-15U-34312022-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-001120901902030-06-15U-4003Drug product2024-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-00195393022030-06-15Drug product2017-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-002114199142030-06-15U-34312022-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-002120901902030-06-15U-4003Drug product2024-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201656-00295393022030-06-15Drug product2017-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-001114199142030-06-15U-34312022-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-001120901902030-06-15U-4003Drug product2024-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-00195393022030-06-15Drug product2017-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-002114199142030-06-15U-34312022-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-002120901902030-06-15U-4003Drug product2024-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201656-00295393022030-06-15Drug product2017-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N201656-001114199142030-06-15U-34312022-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-001120901902030-06-15U-4003Drug product2024-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-00195393022030-06-15Drug product2017-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-002114199142030-06-15U-34312022-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-002120901902030-06-15U-4003Drug product2024-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201656-00295393022030-06-15Drug product2017-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-001114199142030-06-15U-34312022-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-001120901902030-06-15U-4003Drug product2024-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-00195393022030-06-15Drug product2017-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201656-002114199142030-06-15U-34312022-09-20fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N201656-001NP2020-03-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N201656-002NP2020-03-0374a2ff9319b5…
2020-12-22 03:56 UTC2020-12N201656-001NP2020-03-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N201656-002NP2020-03-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201656-001NP2020-03-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N201656-002NP2020-03-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201656-001NP2020-03-033f01610625f2…
2019-12-14 00:12 UTC2019-12N201656-002NP2020-03-033f01610625f2…
2019-09-15 20:21 UTC2019-09N201656-001NP2020-03-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N201656-002NP2020-03-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N201656-001NP2020-03-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N201656-002NP2020-03-03ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71758-106-55GM - Gram71758-10618d5037f-b178-4b9f-abeb-bf86c4df2b2e12018-03-08