Home NDC 69918-501 Desmopressin Acetate
Product NDC 69918-501
11-digit product format 699180501
Labeler code 69918
Product ID 69918-501_5cca6c70-48ee-42ed-b0dc-5e61f7164541
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form SPRAY
Route NASAL
Labeler Amring Pharmaceuticals, Inc.
Application NDA017922
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-06
Marketing end 2022-05-31
Substance DESMOPRESSIN ACETATE
Active strength 10 ug/.1mL
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 · 24 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 69918-501-05 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 69918-501-05 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69918-501-05 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69918-501-05 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69918-501-05 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69918-501-05 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69918-501-05 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69918-501-05 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69918-501-05 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69918-501-05 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69918-501-05 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69918-501-05 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 3 of 4 · 129 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 2019-12-14 00:12 UTC 2019-12 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, RS, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017922-002 DDAVP 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED / NASAL RLD 1989-02-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N017922-001 DDAVP 0.01% SOLUTION / NASAL AB RLD, RS, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017922-002 DDAVP 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED / NASAL RLD 1989-02-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1996-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 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 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 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 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 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 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 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 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 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 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 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 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 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 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 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 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 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 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 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 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N017922-001 DDAVP 0.01% SOLUTION / NASAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 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 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017922-003 DDAVP (NEEDS NO REFRIGERATION) 0.01MG/SPRAY SPRAY, METERED / NASAL RLD 1996-08-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69918-501-05 69918050105 1 BOTTLE, SPRAY in 1 CARTON (69918-501-05) > 5 mL in 1 BOTTLE, SPRAY 2016-04-06 2022-05-31 No No Current