Stimate

Product NDC: 55566-3000
Requested package NDC: 55566-3000-0
11-digit product format: 555663000
Labeler code: 55566
Product ID: 55566-3000_6beb1a83-b970-4d4a-965c-2972718e5916
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desmopressin acetate
Dosage form: SPRAY
Route: NASAL
Labeler: Ferring Pharmaceuticals Inc.
Application: NDA020355
Marketing category: NDA
Marketing start: 2025-06-25
Substance: DESMOPRESSIN ACETATE
Active strength: 1.5 mg/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: 2027-12-31
Current FDA listing: Yes

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
N020355-001	STIMATE	DESMOPRESSIN ACETATE	0.15MG/SPRAY	SPRAY, METERED / NASAL			1994-03-07
N020355-002	STIMATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		RLD	2007-10-24

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020355-001	STIMATE	0.15MG/SPRAY	SPRAY, METERED / NASAL		1994-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020355-002	STIMATE (NEEDS NO REFRIGERATION)	0.15MG/SPRAY	SPRAY, METERED / NASAL	RLD	2007-10-24	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Stimate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESMOPRESSIN ACETATE	1.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XB13HYU18U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797859	Internal RxNorm lookup
1797861	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f5ada39c-20ed-4500-9dce-1e4ab642a358	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stimate	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	f5ada39c-20ed-4500-9dce-1e4ab642a358	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020355 application number: NDA020355 ndc (package): 55566-3000-0 ndc (product): 55566-3000 ndc11 (package): 55566300000

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	Sample	Exclude flag	Status
55566-3000-0	55566300000	2.5 mL in 1 BOTTLE, SPRAY (55566-3000-0)	2.5 ml	2025-06-25	No	No	Current