Home NDC 71863-123 DESMODA
Product NDC 71863-123
11-digit product format 718630123
Labeler code 71863
Product ID 71863-123_4c0e1356-d150-cfb4-e063-6294a90acd27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application NDA219873
Marketing category NDA
Marketing start 2026-03-02
Substance DESMOPRESSIN ACETATE
Active strength .05 mg/mL
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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219873-001 DESMODA DESMOPRESSIN ACETATE 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-02-25
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219873-001 12214010 2044-04-03 Drug product 2026-03-23 N219873-001 12343372 2044-04-03 U-4432 Drug product 2026-03-23
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 N219873-001 DESMODA 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-02-25 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219873-001 DESMODA 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-02-25 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N219873-001 12214010 2044-04-03 Drug product 2026-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219873-001 12343372 2044-04-03 U-4432 Drug product 2026-03-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219873-001 12214010 2044-04-03 Drug product 2026-03-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219873-001 12343372 2044-04-03 U-4432 Drug product 2026-03-23 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base DESMODA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESMOPRESSIN ACETATE .05 mg/mL
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 2738083 Internal RxNorm lookup 2738090 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 71863-123-14 DESMODA 145 mL in 1 BOTTLE SOLUTION 145 1
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 DESMODA DESMOPRESSIN ACETATE ORAL SOLUTION Eton Pharmaceuticals, Inc. 4c0e1356-d14f-cfb4-e063-6294a90acd27 2026-03-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 219873 application number: NDA219873 ndc (product): 71863-123
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71863-123-14 71863012314 145 mL in 1 BOTTLE (71863-123-14) 145 ml 2026-03-02 No No Current