FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
23155-489
11-digit product format
231550489
Labeler code
23155
Product ID
23155-489_3ed8c1cf-5b26-49fc-adb2-264572e68cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA207880
Marketing category
ANDA
Marketing start
2017-05-26
Substance
DESMOPRESSIN ACETATE
Active strength
.1 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.1 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-489-012020-03-19C16284748780-19d75b9d0-36d0-f424-e053-dadaa90a57ceDesmopressin Acetate Tablets Rx only
23155-489-052020-03-19C16284748780-19d75b9d0-36d0-f424-e053-dadaa90a57ceDesmopressin Acetate Tablets Rx only
23155-489-012020-01-31C16284748780-19d75b9d0-36d0-f424-e053-dadaa90a57ceDesmopressin Acetate Tablets Rx only
23155-489-052020-01-31C16284748780-19d75b9d0-36d0-f424-e053-dadaa90a57ceDesmopressin Acetate Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-489-01Desmopressin Acetate100 in 1 BOTTLETABLET1007
23155-489-05Desmopressin Acetate500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-489-01EA - Each23155-4896650d4b5-4040-4909-ba3b-7398a760c28012018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-489DESMOPRESSIN ACETATE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20220331_e87b6cfd-5677-4398-883d-7ced5dd678ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849515desmopressin acetate 0.1 MG Oral TabletPSNe87b6cfd-5677-4398-883d-7ced5dd678ef7
833008desmopressin acetate 0.2 MG Oral TabletPSNe87b6cfd-5677-4398-883d-7ced5dd678ef7
849515desmopressin acetate 0.1 MG Oral TabletSCDe87b6cfd-5677-4398-883d-7ced5dd678ef7
833008desmopressin acetate 0.2 MG Oral TabletSCDe87b6cfd-5677-4398-883d-7ced5dd678ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-489-0123155048901100 TABLET in 1 BOTTLE (23155-489-01) 100 tablet2017-05-260000-00-00NoNoCurrent
23155-489-0523155048905500 TABLET in 1 BOTTLE (23155-489-05) 500 tablet2017-05-260000-00-00NoNoCurrent