FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
10702-170
11-digit product format
107020170
Labeler code
10702
Product ID
10702-170_11e764a6-0d02-ec11-e063-6394a90a195e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, INC.
Application
ANDA210371
Marketing category
ANDA
Marketing start
2019-01-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-170-012024-02-21C16284748780-11030e365-0f53-111a-e063-dadaa90a10e2Desmopressin Acetate Tablets
10702-170-012024-01-30C16284748780-11030e365-0f53-111a-e063-dadaa90a10e2Desmopressin Acetate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-170-01Desmopressin Acetate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-170-01EA - Each10702-170c2686852-9b01-4a71-afe8-a26391161b9b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-170DESMOPRESSIN ACETATE TABLET [KVK-TECH, INC.]4Current NDC, Legacy NDC, 1 package rows20240223_9fba5e90-f541-4588-a5e9-b56198f17e87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849515desmopressin acetate 0.1 MG Oral TabletPSN9fba5e90-f541-4588-a5e9-b56198f17e874
833008desmopressin acetate 0.2 MG Oral TabletPSN9fba5e90-f541-4588-a5e9-b56198f17e874
849515desmopressin acetate 0.1 MG Oral TabletSCD9fba5e90-f541-4588-a5e9-b56198f17e874
833008desmopressin acetate 0.2 MG Oral TabletSCD9fba5e90-f541-4588-a5e9-b56198f17e874
833008desmopressin acetate 0.2 MG Oral TabletPSNf306e2d4-781f-ff8f-e053-2a95a90ad15b2
833008desmopressin acetate 0.2 MG Oral TabletSCDf306e2d4-781f-ff8f-e053-2a95a90ad15b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-170-0110702017001100 TABLET in 1 BOTTLE (10702-170-01) 100 tablet2019-01-280000-00-00NoNoCurrent