Home NDC 59651-249 Desmopressin Acetate
Product NDC 59651-249
11-digit product format 596510249
Labeler code 59651
Product ID 59651-249_24866ad0-94db-46a2-96c0-b362acd0271a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desmopressin acetate
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213095
Marketing category ANDA
Marketing start 2024-03-21
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 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 A213095-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 A213095-002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21
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.
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 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213095-001 DESMOPRESSIN ACETATE 0.1MG TABLET / ORAL AB 2024-03-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213095-002 DESMOPRESSIN ACETATE 0.2MG TABLET / ORAL AB 2024-03-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 59651-249-01 Desmopressin Acetate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-249 DESMOPRESSIN ACETATE TABLET [AUROBINDO PHARMA LIMITED] 1 Current NDC, 1 package rows 20240328_24866ad0-94db-46a2-96c0-b362acd0271a.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-249-01 59651024901 100 TABLET in 1 BOTTLE (59651-249-01) 100 tablet 2024-03-21 No No Current