FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
69918-201
11-digit product format
699180201
Labeler code
69918
Product ID
69918-201_8f843a4f-10ba-4f8c-a86e-f599dbb7f322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Nordic Pharma, Inc.
Application
NDA019955
Marketing category
NDA
Marketing start
2015-12-10
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
69918-201-01Desmopressin Acetate100 in 1 BOTTLETABLET1008
69918-201-01Desmopressin Acetate1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-201-01EA - Each69918-20168509e93-f61f-4289-8e38-ddd11d391bdd12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Desmopressin AcetateACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
desmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
PovidonesINACTIVE INGREDIENTFZ989GH94EDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-201DESMOPRESSIN ACETATE TABLET [NORDIC PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20241210_c01048e8-d28f-4085-9c37-3d5d48395a77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833008desmopressin acetate 0.2 MG Oral TabletPSN52133714-37d1-458d-9839-f0bd206711ea101
833008desmopressin acetate 0.2 MG Oral TabletSCD52133714-37d1-458d-9839-f0bd206711ea101
849515desmopressin acetate 0.1 MG Oral TabletPSNc01048e8-d28f-4085-9c37-3d5d48395a778
833008desmopressin acetate 0.2 MG Oral TabletPSNc01048e8-d28f-4085-9c37-3d5d48395a778
849515desmopressin acetate 0.1 MG Oral TabletSCDc01048e8-d28f-4085-9c37-3d5d48395a778
833008desmopressin acetate 0.2 MG Oral TabletSCDc01048e8-d28f-4085-9c37-3d5d48395a778

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69918-201-01699180201011 BOTTLE in 1 CARTON (69918-201-01) / 100 TABLET in 1 BOTTLE1 bottle2015-12-100000-00-00NoNoCurrent