FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
60505-0258
11-digit product format
605050258
Labeler code
60505
Product ID
60505-0258_41d13d8f-eeae-838d-fd10-bf7f568e903b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desmopressin acetate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077414
Marketing category
ANDA
Marketing start
2006-03-07
Substance
DESMOPRESSIN ACETATE
Active strength
.2 mg/1
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 ACETATE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui833008, 849515

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
60505-0258-1Desmopressin Acetate100 in 1 BOTTLETABLET1009
60505-0258-3Desmopressin Acetate30 in 1 BOTTLETABLET309
60505-0258-8Desmopressin Acetate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0258-1EA - Each60505-0258a292e59e-c3fa-4ca5-b0e5-07cbb50d33bc12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESMOPRESSIN ACETATEACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
DesmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0258DESMOPRESSIN ACETATE TABLET [APOTEX CORP.]8Current NDC, Legacy NDC, 3 package rows20240926_72aeef35-c102-b628-0219-9822651887eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833008desmopressin acetate 0.2 MG Oral TabletPSNdc9b0dad-d265-4dff-8191-d936280d85a2102
833008desmopressin acetate 0.2 MG Oral TabletSCDdc9b0dad-d265-4dff-8191-d936280d85a2102
849515desmopressin acetate 0.1 MG Oral TabletPSN72aeef35-c102-b628-0219-9822651887eb9
833008desmopressin acetate 0.2 MG Oral TabletPSN72aeef35-c102-b628-0219-9822651887eb9
849515desmopressin acetate 0.1 MG Oral TabletSCD72aeef35-c102-b628-0219-9822651887eb9
833008desmopressin acetate 0.2 MG Oral TabletSCD72aeef35-c102-b628-0219-9822651887eb9
849515desmopressin acetate 0.1 MG Oral TabletPSN0d447b48-3f4b-430e-9e68-d8b9401c002e5
833008desmopressin acetate 0.2 MG Oral TabletPSN0d447b48-3f4b-430e-9e68-d8b9401c002e5
849515desmopressin acetate 0.1 MG Oral TabletSCD0d447b48-3f4b-430e-9e68-d8b9401c002e5
833008desmopressin acetate 0.2 MG Oral TabletSCD0d447b48-3f4b-430e-9e68-d8b9401c002e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0258-160505025801100 TABLET in 1 BOTTLE (60505-0258-1) 100 tablet2006-03-070000-00-00NoNoCurrent
60505-0258-36050502580330 TABLET in 1 BOTTLE (60505-0258-3) 30 tablet2006-03-070000-00-00NoNoCurrent
60505-0258-8605050258081000 TABLET in 1 BOTTLE (60505-0258-8) 1000 tablet2006-03-070000-00-00NoNoCurrent