NOCDURNA

Product NDC: 54436-350
11-digit product format: 544360350
Labeler code: 54436
Product ID: 54436-350_24aa2c46-f63b-49c2-932e-8b9cbadd415a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DESMOPRESSIN ACETATE
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Antares Pharma, Inc.
Application: NDA022517
Marketing category: NDA
Marketing start: 2021-08-06
Marketing end: 0000-00-00
Substance: DESMOPRESSIN ACETATE
Active strength: 55 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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54436-350		D	Discontinued by firm		2026-08-17
excluded package	package	54436-350	54436-350-30	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54436-350-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54436-350-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022517-001	NOCDURNA	DESMOPRESSIN ACETATE	0.0277MG	TABLET / SUBLINGUAL		RLD	2018-06-21
N022517-002	NOCDURNA	DESMOPRESSIN ACETATE	0.0553MG	TABLET / SUBLINGUAL		RLD	2018-06-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022517-001	11020448	2029-05-21	U-2327	2021-06-17
N022517-001	11963995	2029-05-21	U-2327	2024-05-21
N022517-001	9974826	2030-04-13	U-2326	2018-07-19
N022517-002	10137167	2029-05-21	U-2327	2018-12-12
N022517-002	11963995	2029-05-21	U-2327	2024-05-21
N022517-002	9974826	2030-04-13	U-2327	2018-07-19

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022517-001	NOCDURNA	0.0277MG	TABLET / SUBLINGUAL	RLD	2018-06-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022517-002	NOCDURNA	0.0553MG	TABLET / SUBLINGUAL	RLD, RS	2018-06-21	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 546 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	10137167	2029-05-21	U-2327		2018-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	11963995	2029-05-21	U-2327		2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022517-002	9974826	2030-04-13	U-2327		2018-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	7560429	2024-02-02	U-2326	Drug product	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	11020448	2029-05-21	U-2327		2021-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	11963995	2029-05-21	U-2327		2024-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022517-001	9974826	2030-04-13	U-2326		2018-07-19	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022517-001	NP	2021-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022517-002	NP	2021-06-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022517-001	NP	2021-06-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022517-002	NP	2021-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022517-001	NP	2021-06-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022517-002	NP	2021-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022517-001	NP	2021-06-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022517-002	NP	2021-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022517-001	NP	2021-06-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022517-002	NP	2021-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022517-001	NP	2021-06-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022517-002	NP	2021-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022517-001	NP	2021-06-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022517-002	NP	2021-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022517-001	NP	2021-06-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022517-002	NP	2021-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022517-001	NP	2021-06-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022517-002	NP	2021-06-21	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54436-350-10	EA - Each	54436-350	5c0b0bb3-e54b-4173-b5f2-cf301ba02fcf	1	2022-01-06
54436-350-30	EA - Each	54436-350	19f6a3ea-f584-4378-944b-6b8b2006f4de	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54436-350	NOCDURNA (DESMOPRESSIN ACETATE) TABLET [ANTARES PHARMA, INC.]	3	Legacy NDC	20231021_cf51914a-55df-4b4a-8ea8-c7af257c1d59.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XB13HYU18U	DESMOPRESSIN ACETATE	62357-86-2	DESMOPRESSIN ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54436-350-30	54436035030	3 BLISTER PACK in 1 CARTON (54436-350-30) > 10 TABLET in 1 BLISTER PACK (54436-350-10)	3 blister pack	2021-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOCDURNA	Antares Pharma, Inc. \| Ferring Production Inc. \| Catalent Pharma Solutions Limited \| Ferring GmbH \| Polypeptide Laboratories (Sweden) AB \| Ferring International Center SA	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	3