Home NDC 16714-884-01 Desmopressin Acetate
Product NDC 16714-884
Requested package NDC 16714-884-01
11-digit product format 167140884
Labeler code 16714
Product ID 16714-884_70b95626-59a2-4552-84e1-f0063ee9c452
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form TABLET
Route ORAL
Labeler Northstar Rx LLC
Application ANDA201831
Marketing category ANDA
Marketing start 2015-05-28
Marketing end 0000-00-00
Substance DESMOPRESSIN ACETATE
Active strength 0 mg/1
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 2020-12-31
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 A201831-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2015-05-28 A201831-002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2015-05-28
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 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2015-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2015-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2015-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2015-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2015-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2015-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2015-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2015-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201831-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2015-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201831-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2015-05-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
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 Marketing end Sample Exclude flag Status 16714-884-01 16714088401 100 TABLET in 1 BOTTLE (16714-884-01) 100 tablet 2018-12-31 0000-00-00 No No Current