NDC 55566-5050

NOCDURNA

Desmopressin Acetate

NOCDURNA is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is Desmopressin Acetate.

Product ID55566-5050_763a3d42-80dc-491a-b67d-7098d8cafb0b
NDC55566-5050
Product TypeHuman Prescription Drug
Proprietary NameNOCDURNA
Generic NameDesmopressin Acetate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2018-10-22
Marketing CategoryNDA / NDA
Application NumberNDA022517
Labeler NameFerring Pharmaceuticals Inc.
Substance NameDESMOPRESSIN ACETATE
Active Ingredient Strength28 ug/1
Pharm ClassesFactor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55566-5050-1

3 BLISTER PACK in 1 CARTON (55566-5050-1) > 10 TABLET in 1 BLISTER PACK (55566-5050-0)
Marketing Start Date2018-10-22
Marketing End Date2022-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55566-5050-0 [55566505000]

NOCDURNA TABLET
Marketing CategoryNDA
Application NumberNDA022517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-29

NDC 55566-5050-1 [55566505001]

NOCDURNA TABLET
Marketing CategoryNDA
Application NumberNDA022517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-29

Drug Details

Active Ingredients

IngredientStrength
DESMOPRESSIN ACETATE27.7 ug/1

OpenFDA Data

SPL SET ID:8ef937d4-0bb5-46bd-9b53-9b14b9d2738f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2048718
  • 2048720
  • 2048722
  • 2048716

    • Pharmacological Class

    • Factor VIII Activator [EPC]
    • Increased Coagulation Factor VIII Activity [PE]
    • Increased Coagulation Factor VIII Concentration [PE]
    • Vasopressin Analog [EPC]
    • Vasopressins [CS]

    NDC Crossover Matching brand name "NOCDURNA" or generic name "Desmopressin Acetate"

    NDCBrand NameGeneric Name
    54436-325NOCDURNADESMOPRESSIN ACETATE
    55566-5050NOCDURNANOCDURNA
    55566-5070NOCDURNANOCDURNA
    0115-1646Desmopressin AcetateDesmopressin Acetate
    0115-1647Desmopressin AcetateDesmopressin Acetate
    0409-2265Desmopressin AcetateDesmopressin Acetate
    0517-4310Desmopressin AcetateDesmopressin Acetate
    0591-2464Desmopressin AcetateDesmopressin Acetate
    0591-2465Desmopressin AcetateDesmopressin Acetate
    0615-7549Desmopressin AcetateDesmopressin Acetate
    0703-5051Desmopressin acetateDesmopressin acetate
    0703-5054Desmopressin acetateDesmopressin acetate
    10702-169Desmopressin AcetateDesmopressin Acetate
    10702-170Desmopressin AcetateDesmopressin Acetate
    16714-015Desmopressin AcetateDesmopressin Acetate
    16714-883Desmopressin AcetateDesmopressin Acetate
    16714-884Desmopressin AcetateDesmopressin Acetate
    23155-489Desmopressin AcetateDesmopressin Acetate
    23155-490Desmopressin AcetateDesmopressin Acetate
    24208-342Desmopressin AcetateDesmopressin Acetate
    25021-460desmopressin acetatedesmopressin acetate
    25021-461desmopressin acetatedesmopressin acetate
    43598-053Desmopressin AcetateDesmopressin Acetate
    43598-931DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE
    47335-788Desmopressin AcetateDesmopressin Acetate
    50268-220Desmopressin AcetateDesmopressin Acetate
    50268-221Desmopressin AcetateDesmopressin Acetate
    0053-6871StimateDESMOPRESSIN ACETATE

    Trademark Results [NOCDURNA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOCDURNA
    NOCDURNA
    76698840 4405021 Live/Registered
    Ferring B.V.
    2009-08-07
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.