FDA.reportPublic FDA data

DESMOPRESSIN ACETATE

Product NDC
60505-0815
11-digit product format
605050815
Labeler code
60505
Product ID
60505-0815_f90935bd-bb23-2f9c-3271-8508e92d45c4
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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DESMOPRESSIN ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE10 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui849506

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60505-0815-02025-08-22C16284748780-13b156c62-3286-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use DESMOPRESSIN NASAL SPRAY safely and effectively. See full prescribing information for DESMOPRESSIN NASAL SPRAY. DESMOPRESSIN nasal spray Initial U.S. Approval: 1978
60505-0815-02025-07-29C16284748780-13b156c62-3286-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use DESMOPRESSIN NASAL SPRAY safely and effectively. See full prescribing information for DESMOPRESSIN NASAL SPRAY. DESMOPRESSIN nasal spray Initial U.S. Approval: 1978

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