Home NDC 0053-6871-00 Stimate
Product NDC 0053-6871
Requested package NDC 0053-6871-00
11-digit product format 000536871
Labeler code 0053
Product ID 0053-6871_03564e71-00bc-484c-8fa8-878820c6103c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DESMOPRESSIN ACETATE
Dosage form SPRAY, METERED
Route NASAL
Labeler CSL Behring LLC
Application NDA020355
Marketing category NDA
Marketing start 1994-07-14
Marketing end 2022-09-30
Substance DESMOPRESSIN ACETATE
Active strength 2 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 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 · 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 · 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 · 84 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 2026-08-18 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…2022-03-09 01:35 UTC 2022-03 N020355-001 STIMATE 0.15MG/SPRAY SPRAY, METERED / NASAL 1994-03-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020355-002 STIMATE (NEEDS NO REFRIGERATION) 0.15MG/SPRAY SPRAY, METERED / NASAL RLD 2007-10-24 bb7c543d1eb4…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded desmopressin acetate ACTIVE INGREDIENT XB13HYU18U STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 desmopressin ACTIVE MOIETY ENR1LLB0FP STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 Benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 Sodium Phosphate, Dibasic, Dihydrate INACTIVE INGREDIENT 94255I6E2T STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6 Water INACTIVE INGREDIENT 059QF0KO0R STIMATE (DESMOPRESSIN ACETATE) SPRAY, METERED [CSL BEHRING LLC] 6
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0053-6871-00 00053687100 1 BOTTLE, SPRAY in 1 CARTON (0053-6871-00) > 2.5 mL in 1 BOTTLE, SPRAY 2011-09-16 2022-09-30 No No Current