FDA.reportPublic FDA data

desmopressin acetate

Product NDC
25021-461
11-digit product format
250210461
Labeler code
25021
Product ID
25021-461_1d8f37fc-befe-491a-a90d-f24568660cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desmopressin acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA204751
Marketing category
ANDA
Marketing start
2018-03-15
Substance
DESMOPRESSIN ACETATE
Active strength
40 ug/10mL
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 ACETATE40 ug/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui849501

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdacProduct name620250127
64db728f-18f9-4c58-ba09-60fd6f75f709Product name220190613
aa3ade84-795a-4f84-bfdf-ebe397f656f5Product name120190402
d8c9f9fc-e302-45b4-9b21-a802f2592402Product name120180810
4bbcef53-5c79-462a-b7ba-cff48fe1fb5aProduct name120171129
74cda04a-3bd1-4535-800b-d9b9265e3211Product name220171129
50d55b09-49b8-f134-6bdc-eb6402b911dcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-461-10desmopressin acetate1 in 1 CARTONINJECTION, SOLUTION15
25021-461-10desmopressin acetate10 mL in 1 VIALINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-461-10ML - Milliliter25021-4613686155b-a997-4943-a68f-1f0ed873b08912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-461DESMOPRESSIN ACETATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240507_40752c75-d09b-4013-9024-442048145b63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN40752c75-d09b-4013-9024-442048145b635
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD40752c75-d09b-4013-9024-442048145b635
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY40752c75-d09b-4013-9024-442048145b635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-461-10250210461101 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL1 vial2018-03-150000-00-00NoNoCurrent