Home NDC 0591-2464 Desmopressin Acetate
Product NDC 0591-2464
11-digit product format 005912464
Labeler code 0591
Product ID 0591-2464_f1a3927d-c80e-48cf-9079-9c50406879be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA076470
Marketing category ANDA
Marketing start 2011-08-15
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 · 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 0591-2464-01 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 A076470-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 A076470-002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01
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 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL 2005-07-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL 2005-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2005-07-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2005-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2005-07-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2005-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2005-07-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2005-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2005-07-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2005-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076470-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2005-07-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076470-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2005-07-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESMOPRESSIN ACETATE ACTIVE INGREDIENT XB13HYU18U DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 DESMOPRESSIN ACTIVE MOIETY ENR1LLB0FP DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T DESMOPRESSIN ACETATE TABLET [ACTAVIS PHARMA, INC.] 4 DESMOPRESSIN ACETATE ACTIVE INGREDIENT XB13HYU18U DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 DESMOPRESSIN ACTIVE MOIETY ENR1LLB0FP DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING] 3 DESMOPRESSIN ACETATE ACTIVE INGREDIENT XB13HYU18U DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 DESMOPRESSIN ACTIVE MOIETY ENR1LLB0FP DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE) TABLET [AVPAK] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-2464-01 00591246401 100 TABLET in 1 BOTTLE, PLASTIC (0591-2464-01) 100 tablet 2011-08-15 0000-00-00 No No Current