FDA.reportPublic FDA data

Desmopressin acetate

Product NDC
71288-441
11-digit product format
712880441
Labeler code
71288
Product ID
71288-441_4cd11e26-c85f-447c-8a97-56215fdf7b1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin acetate
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA074888
Marketing category
ANDA
Marketing start
2026-02-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desmopressin acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui849501, 1723232

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
71288-441-10Desmopressin acetate1 in 1 CARTONINJECTION12
71288-441-10Desmopressin acetate10 mL in 1 VIALINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-441DESMOPRESSIN ACETATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240802_2a2a6eba-c5bf-4ee4-bb18-c992ae59dce5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY2a2a6eba-c5bf-4ee4-bb18-c992ae59dce52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-441-10712880441101 VIAL in 1 CARTON (71288-441-10) / 10 mL in 1 VIAL1 vial2026-02-13NoNoHistorical