Home NDC 71758-107 Noctiva
Product NDC 71758-107
11-digit product format 717580107
Labeler code 71758
Product ID 71758-107_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 2020-03-31
Substance DESMOPRESSIN ACETATE
Active strength 2 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
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.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201656-001 NOCTIVA DESMOPRESSIN ACETATE 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 N201656-002 NOCTIVA DESMOPRESSIN ACETATE 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201656-001 11419914 2030-06-15 U-3431 2022-09-20 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 N201656-002 9539302 2030-06-15 Drug product 2017-03-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201656-001 NOCTIVA 0.00083MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201656-002 NOCTIVA 0.00166MG/SPRAY SPRAY, METERED / NASAL RLD 2017-03-03 4b0b4de00fa7…
Observed Orange Book patent history# Patent history page 1 of 7 · 257 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-002 12090190 2030-06-15 U-4003 Drug product 2024-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201656-002 9539302 2030-06-15 Drug product 2017-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-001 11419914 2030-06-15 U-3431 2022-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-001 12090190 2030-06-15 U-4003 Drug product 2024-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-001 9539302 2030-06-15 Drug product 2017-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201656-002 11419914 2030-06-15 U-3431 2022-09-20 fd3edfee7708…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.