NOCDURNA
These highlights do not include all the information needed to use NOCDURNA safely and effectively. See full prescribing information for NOCDURNA. NOCDURNA (desmopressin acetate) sublingual tablets Initial U.S. Approval: 1978
Approved
Approval ID
cf51914a-55df-4b4a-8ea8-c7af257c1d59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Antares Pharma, Inc.
DUNS: 085369585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DESMOPRESSIN ACETATE
PRODUCT DETAILS
NDC Product Code54436-350
Application NumberNDA022517
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateOctober 19, 2023
Generic NameDESMOPRESSIN ACETATE
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MARINE NON-GELLING GELATIN, HIGH MWInactive
Code: AHQ60JKI5D
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 55.3 ug in 1 1
Code: XB13HYU18U
Classification: ACTIB
DESMOPRESSIN ACETATE
PRODUCT DETAILS
NDC Product Code54436-325
Application NumberNDA022517
Marketing CategoryC73594
Route of AdministrationSUBLINGUAL
Effective DateOctober 19, 2023
Generic NameDESMOPRESSIN ACETATE
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MARINE NON-GELLING GELATIN, HIGH MWInactive
Code: AHQ60JKI5D
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 27.7 ug in 1 1
Code: XB13HYU18U
Classification: ACTIB