FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
62756-161
11-digit product format
627560161
Labeler code
62756
Product ID
62756-161_670b5d06-9692-4b0b-999c-b7caf351830e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
SOLUTION
Route
NASAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077212
Marketing category
ANDA
Marketing start
2012-04-14
Marketing end
0000-00-00
Substance
DESMOPRESSIN ACETATE
Active strength
0 mg/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
2019-12-31
Current FDA listing
Historical FDA.report record

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
62756-161-912020-01-31C16284748780-19d75b9d0-911b-f424-e053-dadaa90a57ceDesmopressin Nasal Spray Solution, USP 0.01%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-161-91Desmopressin Acetate5 mL in 1 BOTTLE, PUMPSOLUTION53
62756-161-91Desmopressin Acetate1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-161-91ML - Milliliter62756-161b85170c3-0f4a-4666-906c-4ab299a1640812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESMOPRESSIN ACETATEACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
DESMOPRESSINACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CHLOROBUTANOL HEMIHYDRATEINACTIVE INGREDIENT3X4P6271OXDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
WATERINACTIVE INGREDIENT059QF0KO0RDESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-161DESMOPRESSIN ACETATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Legacy NDC, 2 package rows20181026_ceee4883-6c49-4538-a747-354d0743b221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849506desmopressin acetate 0.01 % Nasal SprayPSNceee4883-6c49-4538-a747-354d0743b2213
849506desmopressin acetate 0.01 MG/ACTUAT Nasal SpraySCDceee4883-6c49-4538-a747-354d0743b2213
849506desmopressin acetate 0.01 % Nasal SpraySYceee4883-6c49-4538-a747-354d0743b2213
849506desmopressin acetate 10 MCG per 0.1 ML Nasal SpraySYceee4883-6c49-4538-a747-354d0743b2213
849506desmopressin acetate 10 MCG/ACTUAT Nasal SpraySYceee4883-6c49-4538-a747-354d0743b2213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
62756-161-91627560161915 mL in 1 BOTTLE, PUMP5 mlHistorical