FDA.reportPublic FDA data

DESMOPRESSIN ACETATE

Product NDC
72843-461
11-digit product format
728430461
Labeler code
72843
Product ID
72843-461_2e790f05-a105-6fda-e063-6294a90a146c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESMOPRESSIN ACETATE
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
UBI Pharma Inc.
Application
ANDA210223
Marketing category
ANDA
Marketing start
2020-09-17
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

Additional Listing Data#

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

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
72843-461-10DESMOPRESSIN ACETATE1 mL in 1 VIALINJECTION16
72843-461-10DESMOPRESSIN ACETATE10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72843-461DESMOPRESSIN ACETATE INJECTION [UBI PHARMA INC.]6Current NDC, Legacy NDC, 2 package rows20250221_b01c22dc-eecd-11b2-e053-2a95a90a529a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSNb01c22dc-eecd-11b2-e053-2a95a90a529a6
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSNb01c22dc-eecd-11b2-e053-2a95a90a529a6
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCDb01c22dc-eecd-11b2-e053-2a95a90a529a6
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCDb01c22dc-eecd-11b2-e053-2a95a90a529a6
1723232desmopressin acetate 4 MCG per 1 ML InjectionSYb01c22dc-eecd-11b2-e053-2a95a90a529a6
849501desmopressin acetate 4 MCG/ML Injectable SolutionSYb01c22dc-eecd-11b2-e053-2a95a90a529a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72843-461-107284304611010 VIAL in 1 CARTON (72843-461-10) / 1 mL in 1 VIAL10 vial2020-09-170000-00-00NoNoCurrent