FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
69918-899
11-digit product format
699180899
Labeler code
69918
Product ID
69918-899_13ec577b-9bd8-4429-ad53-f8bf5a118995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Nordic Pharma, Inc.
Application
NDA018938
Marketing category
NDA
Marketing start
2016-01-20
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69918-899-01Desmopressin Acetate1 mL in 1 AMPULESOLUTION113
69918-899-10Desmopressin Acetate1 mL in 1 AMPULESOLUTION113
69918-899-10Desmopressin Acetate10 in 1 CARTONSOLUTION1013
69918-899-11Desmopressin Acetate1 mL in 1 AMPULESOLUTION17
69918-899-11Desmopressin Acetate10 in 1 CARTONSOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-899-01ML - Milliliter69918-899e6bb53a8-b040-4696-b913-dfa0b5a56d0e12016-06-14
69918-899-10ML - Milliliter69918-8999e34b935-e656-4cd5-b8df-06ebfd5903c312016-02-04
69918-899-11ML - Milliliter69918-899c02abe0d-217d-4652-bd0f-9667f78d02ac12022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Desmopressin AcetateACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
desmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
ChlorobutanolINACTIVE INGREDIENTHM4YQM8WRCDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-899DESMOPRESSIN ACETATE SOLUTION [NORDIC PHARMA, INC.]11Current NDC, Legacy NDC, 3 package rows20250130_29df0492-f7ef-47bb-aa67-4ef9e5c2846f.zip
69918-899DESMOPRESSIN ACETATE SOLUTION [NORDIC PHARMA, INC.]5Current NDC, Legacy NDC, 2 package rows20241211_10b29aa2-274e-4c29-bccd-424bd3761758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN10b29aa2-274e-4c29-bccd-424bd37617587
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD10b29aa2-274e-4c29-bccd-424bd37617587
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY10b29aa2-274e-4c29-bccd-424bd37617587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69918-899-01699180899011 mL in 1 AMPULE (69918-899-01) 1 ml2016-01-200000-00-00NoNoCurrent
69918-899-106991808991010 AMPULE in 1 CARTON (69918-899-10) / 1 mL in 1 AMPULE10 ampule2016-01-200000-00-00NoNoCurrent
69918-899-116991808991110 AMPULE in 1 CARTON (69918-899-11) / 1 mL in 1 AMPULE10 ampule2022-01-070000-00-00NoNoCurrent