NDC 0310-0088

Daliresp

Roflumilast

Daliresp is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Roflumilast.

Product ID0310-0088_5daa2c1b-1fe2-4c32-b17c-fba76ce5965e
NDC0310-0088
Product TypeHuman Prescription Drug
Proprietary NameDaliresp
Generic NameRoflumilast
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-01
Marketing CategoryNDA / NDA
Application NumberNDA022522
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameROFLUMILAST
Active Ingredient Strength250 ug/1
Pharm ClassesPhosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0310-0088-28

1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) > 28 TABLET in 1 BLISTER PACK
Marketing Start Date2018-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-0088-39 [00310008839]

Daliresp TABLET
Marketing CategoryNDA
Application NumberNDA022522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-23

NDC 0310-0088-28 [00310008828]

Daliresp TABLET
Marketing CategoryNDA
Application NumberNDA022522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-23

NDC 0310-0088-95 [00310008895]

Daliresp TABLET
Marketing CategoryNDA
Application NumberNDA022522
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-23

Drug Details

Active Ingredients

IngredientStrength
ROFLUMILAST250 ug/1

OpenFDA Data

SPL SET ID:c9a1d0a8-581f-4f91-a2b8-f419192d0ebf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091839
  • 1091843
  • 2001321
  • 2001319
  • Pharmacological Class

    • Phosphodiesterase 4 Inhibitor [EPC]
    • Phosphodiesterase 4 Inhibitors [MoA]

    NDC Crossover Matching brand name "Daliresp" or generic name "Roflumilast"

    NDCBrand NameGeneric Name
    0310-0088Daliresproflumilast
    0310-0095Daliresproflumilast
    55154-4625Daliresproflumilast
    0378-1905RoflumilastRoflumilast
    13668-476RoflumilastRoflumilast
    31722-623RoflumilastRoflumilast
    42571-259ROFLUMILASTRoflumilast
    43547-005ROFLUMILASTroflumilast
    64380-786roflumilastROFLUMILAST
    68382-969RoflumilastRoflumilast
    70771-1674RoflumilastRoflumilast
    72205-200RoflumilastRoflumilast
    72205-201RoflumilastRoflumilast
    80610-130roflumilastroflumilast

    Trademark Results [Daliresp]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DALIRESP
    DALIRESP
    85265098 4055617 Live/Registered
    Nycomed GmbH
    2011-03-11
    DALIRESP
    DALIRESP
    77947508 4003351 Live/Registered
    Nycomed GmbH
    2010-03-01
    DALIRESP
    DALIRESP
    75876181 not registered Dead/Abandoned
    ALTANA PHARMA AG
    1999-12-21

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