Home NDC 60505-0257 Desmopressin Acetate
Product NDC 60505-0257
11-digit product format 605050257
Labeler code 60505
Product ID 60505-0257_41d13d8f-eeae-838d-fd10-bf7f568e903b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desmopressin acetate
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA077414
Marketing category ANDA
Marketing start 2006-03-07
Substance DESMOPRESSIN ACETATE
Active strength .1 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 2026-12-31
Current FDA listing Yes 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.
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 A077414-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 A077414-002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07
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 · 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 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077414-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2006-03-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077414-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2006-03-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Desmopressin Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESMOPRESSIN ACETATE .1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XB13HYU18U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833008 Internal RxNorm lookup 849515 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0257-1 Desmopressin Acetate 100 in 1 BOTTLE TABLET 100 9 60505-0257-3 Desmopressin Acetate 30 in 1 BOTTLE TABLET 30 9 60505-0257-8 Desmopressin Acetate 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0257 DESMOPRESSIN ACETATE TABLET [APOTEX CORP.] 8 Current NDC, Legacy NDC, 3 package rows 20240926_72aeef35-c102-b628-0219-9822651887eb.zip
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-0257-1 60505025701 100 TABLET in 1 BOTTLE (60505-0257-1) 100 tablet 2006-03-07 0000-00-00 No No Current 60505-0257-3 60505025703 30 TABLET in 1 BOTTLE (60505-0257-3) 30 tablet 2006-03-07 0000-00-00 No No Current 60505-0257-8 60505025708 1000 TABLET in 1 BOTTLE (60505-0257-8) 1000 tablet 2006-03-07 0000-00-00 No No Current