Home NDC 55566-3000 Stimate
Product NDC 55566-3000
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 43 .
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 · 86 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 2026-09-14 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…2019-12-13 00:20 UTC 2019-12 N020355-001 STIMATE 0.15MG/SPRAY SPRAY, METERED / NASAL 1994-03-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020355-002 STIMATE (NEEDS NO REFRIGERATION) 0.15MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2007-10-24 74a2ff9319b5…
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.
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.
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