DDAVP

Product NDC: 55566-2500
Requested package NDC: 55566-2500-0
11-digit product format: 555662500
Labeler code: 55566
Product ID: 55566-2500_9a93db5c-dd74-4b1e-87da-ff46aeadfbe4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: SPRAY
Route: NASAL
Labeler: Ferring Pharmaceuticals Inc.
Application: NDA017922
Marketing category: NDA
Marketing start: 1978-02-21
Marketing end: 2022-06-30
Substance: DESMOPRESSIN ACETATE
Active strength: 0 ug/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55566-2500	55566-2500-0	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017922-001	DDAVP	DESMOPRESSIN ACETATE	0.01%	SOLUTION / NASAL	RLD, Approved before 1982
N017922-002	DDAVP	DESMOPRESSIN ACETATE	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06
N017922-003	DDAVP (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07

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 4 · 126 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	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017922-002	DDAVP	0.01MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1989-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017922-003	DDAVP (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	RLD	1996-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017922-001	DDAVP	0.01%	SOLUTION / NASAL	RLD, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017922-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	N017922-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017922-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017922-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017922-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017922-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-2500-0	ML - Milliliter	55566-2500	8ff838cd-8596-429b-9b98-ac5a3c746223	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Desmopressin Acetate	ACTIVE INGREDIENT	XB13HYU18U	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1
desmopressin	ACTIVE MOIETY	ENR1LLB0FP	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1
Sodium Phosphate, Dibasic, Dihydrate	INACTIVE INGREDIENT	94255I6E2T	DDAVP (DESMOPRESSIN ACETATE) SPRAY [FERRING PHARMACEUTICALS INC.]	1

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55566-2500-0	55566250000	1 BOTTLE, PUMP in 1 CARTON (55566-2500-0) > 5 mL in 1 BOTTLE, PUMP	1978-02-21	2022-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DDAVP	Ferring Pharmaceuticals Inc. \| Ferring GmbH \| Rechon Life Science AB \| Ferring International Center SA \| PolyPeptide Laboratories (Sweden) AB	2021-06-25	HUMAN PRESCRIPTION DRUG LABEL	8