Home NDC 65145-184 Desmopressin Acetate
Product NDC 65145-184
11-digit product format 651450184
Labeler code 65145
Product ID 65145-184_84dbb392-4535-4cbc-af60-75abb494f26e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Caplin Steriles Limited
Application ANDA219981
Marketing category ANDA
Marketing start 2026-03-16
Substance DESMOPRESSIN ACETATE
Active strength 4 ug/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 A219981-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2026-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219981-001 AP
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 A219981-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2026-02-27 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219981-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2026-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219981-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219981-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Desmopressin Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESMOPRESSIN ACETATE 4 ug/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 849501 Internal RxNorm lookup 1723232 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 65145-184-01 Desmopressin Acetate 1 in 1 CARTON INJECTION, SOLUTION 1 1 65145-184-01 Desmopressin Acetate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65145-184-01 65145018401 1 VIAL, MULTI-DOSE in 1 CARTON (65145-184-01) / 10 mL in 1 VIAL, MULTI-DOSE 2026-03-16 No No Current