Home NDC 70518-3493-0 Desmopressin Acetate
Product NDC 70518-3493
Requested package NDC 70518-3493-0
11-digit product format 705183493
Labeler code 70518
Product ID 70518-3493_e7144621-d26e-2d75-e053-2a95a90adc9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA207880
Marketing category ANDA
Marketing start 2022-08-22
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 2023-12-31
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 · 10 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207880-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 A207880-002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207880-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2017-05-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207880-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2017-05-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Desmopressin Acetate DESMOPRESSIN ACETATE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. e87b6cfd-5677-4398-883d-7ced5dd678ef 2022-03-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207880 application number: ANDA207880
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3493-0 70518349300 100 POUCH in 1 BOX (70518-3493-0) > 1 TABLET in 1 POUCH (70518-3493-1) 100 pouch 2022-08-22 0000-00-00 No No Current