FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
68083-550
11-digit product format
680830550
Labeler code
68083
Product ID
68083-550_0f297b51-3d85-43b9-b96b-88a82858fe3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA216922
Marketing category
ANDA
Marketing start
2022-11-16
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
Rxcui1723232

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
68083-550-01Desmopressin Acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15
68083-550-10Desmopressin Acetate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-550DESMOPRESSIN ACETATE INJECTION, SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20221119_7f4e5a22-85e8-4c28-9ebf-d6ebc75ad653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN7f4e5a22-85e8-4c28-9ebf-d6ebc75ad6535
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD7f4e5a22-85e8-4c28-9ebf-d6ebc75ad6535
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY7f4e5a22-85e8-4c28-9ebf-d6ebc75ad6535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-550-01680830550011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
68083-550-106808305501010 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01) 2022-11-160000-00-00NoNoCurrent