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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-350
Application NumberNDA022517
Product Classification
M
Marketing Category
C73594
G
Generic Name
DESMOPRESSIN ACETATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 19, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-325
Application NumberNDA022517
Product Classification
M
Marketing Category
C73594
G
Generic Name
DESMOPRESSIN ACETATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 19, 2023
FDA Product Classification
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