Home NDC 39822-6200 Desmopressin Acetate
Product NDC 39822-6200
11-digit product format 398226200
Labeler code 39822
Product ID 39822-6200_0ec4ffe1-0ee2-fc69-e063-6394a90ab7fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desmopressin acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA210223
Marketing category ANDA
Marketing start 2024-03-22
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210223-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210223-001 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 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210223-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2020-09-17 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 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 39822-6200-1 Desmopressin Acetate 1 mL in 1 VIAL INJECTION, SOLUTION 1 1 39822-6200-2 Desmopressin Acetate 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-6200 DESMOPRESSIN ACETATE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 1 Current NDC, 2 package rows 20240322_1052a869-b64d-655d-e063-6294a90ad0e2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Desmopressin Acetate DESMOPRESSIN ACETATE The J. Molner Company LLC 52680415-52a0-61c2-e063-6294a90ae27e 2026-08-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210223 application number: ANDA210223 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE UBI Pharma Inc. b01c22dc-eecd-11b2-e053-2a95a90a529a 2025-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210223 application number: ANDA210223 Desmopressin Acetate DESMOPRESSIN ACETATE XGen Pharmaceuticals DJB, Inc. 1052a869-b64d-655d-e063-6294a90ad0e2 2024-03-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210223 application number: ANDA210223 ndc (product): 39822-6200 Desmopressin Acetate DESMOPRESSIN ACETATE Avenacy, Inc. c2e21331-4d54-4fa7-8f0d-31fe23a981aa 2024-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210223 application number: ANDA210223
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 39822-6200-1 39822620001 1 mL in 1 VIAL 1 ml Historical 39822-6200-2 39822620002 10 VIAL in 1 CARTON (39822-6200-2) / 1 mL in 1 VIAL (39822-6200-1) 10 vial 2024-03-22 No No Current