DESMOPRESSIN ACETATE

Product NDC
60505-0815
11-digit product format
605050815
Labeler code
60505
Product ID
60505-0815_30550e89-9eed-13de-c2dc-8faea284ffed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESMOPRESSIN ACETATE
Dosage form
SPRAY
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA076703
Marketing category
ANDA
Marketing start
2020-11-30
Substance
DESMOPRESSIN ACETATE TRIHYDRATE
Active strength
10 ug/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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATE0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076703-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALABRS2005-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076703-001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)0.01MG/SPRAYSPRAY, METERED / NASALAB2005-01-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076703-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A076703-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076703-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076703-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076703-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076703-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076703-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076703-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076703-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076703-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076703-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076703-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076703-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076703-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076703-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076703-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076703-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076703-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076703-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076703-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076703-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076703-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076703-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076703-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076703-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076703-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076703-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076703-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076703-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076703-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076703-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076703-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076703-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076703-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076703-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076703-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076703-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076703-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076703-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076703-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DESMOPRESSIN ACETATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE TRIHYDRATE10 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdacProduct name620250127
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
64db728f-18f9-4c58-ba09-60fd6f75f709Product name220190613
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
aa3ade84-795a-4f84-bfdf-ebe397f656f5Product name120190402
d8c9f9fc-e302-45b4-9b21-a802f2592402Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4bbcef53-5c79-462a-b7ba-cff48fe1fb5aProduct name120171129
74cda04a-3bd1-4535-800b-d9b9265e3211Product name220171129
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
50d55b09-49b8-f134-6bdc-eb6402b911dcProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0815-0DESMOPRESSIN ACETATE1 in 1 CARTONSPRAY112
60505-0815-0DESMOPRESSIN ACETATE50 in 1 BOTTLE, SPRAYSPRAY5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0815-0ML - Milliliter60505-0815093d8eed-b031-4805-bd6d-ffc895f0d29e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESMOPRESSIN ACETATEACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
DESMOPRESSINACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RDESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0815DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]11Current NDC, Legacy NDC, 2 package rows20240926_1ac423b8-27a6-4cef-4a82-c50bf81b4f49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849506desmopressin acetate 0.01 % Nasal SprayPSN1ac423b8-27a6-4cef-4a82-c50bf81b4f4912
849506desmopressin acetate 0.01 MG/ACTUAT Nasal SpraySCD1ac423b8-27a6-4cef-4a82-c50bf81b4f4912
849506desmopressin acetate 0.01 % Nasal SpraySY1ac423b8-27a6-4cef-4a82-c50bf81b4f4912
849506desmopressin acetate 10 MCG per 0.1 ML Nasal SpraySY1ac423b8-27a6-4cef-4a82-c50bf81b4f4912
849506desmopressin acetate 10 MCG/ACTUAT Nasal SpraySY1ac423b8-27a6-4cef-4a82-c50bf81b4f4912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0815-0605050815001 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) / 50 SPRAY in 1 BOTTLE, SPRAY2020-11-300000-00-00NoNoCurrent