NDC 0310-0095

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 ID: 0310-0095_5daa2c1b-1fe2-4c32-b17c-fba76ce5965e
• NDC: 0310-0095
• Product Type: Human Prescription Drug
• Proprietary Name: Daliresp
• Generic Name: Roflumilast
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022522
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: ROFLUMILAST
• Active Ingredient Strength: 500 ug/1
• Pharm Classes: Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0310-0095-30

30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0095-30 [00310009530]

Daliresp TABLET

• Marketing Category: NDA
• Application Number: NDA022522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-01

NDC 0310-0095-39 [00310009539]

Daliresp TABLET

• Marketing Category: NDA
• Application Number: NDA022522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-01
• Marketing End Date: 2019-11-30

NDC 0310-0095-90 [00310009590]

Daliresp TABLET

• Marketing Category: NDA
• Application Number: NDA022522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-01

NDC 0310-0095-95 [00310009595]

Daliresp TABLET

• Marketing Category: NDA
• Application Number: NDA022522
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-01

Drug Details

Active Ingredients

Ingredient	Strength
ROFLUMILAST	500 ug/1

OpenFDA Data

• SPL SET ID: c9a1d0a8-581f-4f91-a2b8-f419192d0ebf
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 0P6C6ZOP5U
• 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"

NDC	Brand Name	Generic Name
0310-0088	Daliresp	roflumilast
0310-0095	Daliresp	roflumilast
55154-4625	Daliresp	roflumilast
0378-1905	Roflumilast	Roflumilast
13668-476	Roflumilast	Roflumilast
31722-623	Roflumilast	Roflumilast
42571-259	ROFLUMILAST	Roflumilast
43547-005	ROFLUMILAST	roflumilast
64380-786	roflumilast	ROFLUMILAST
68382-969	Roflumilast	Roflumilast
70771-1674	Roflumilast	Roflumilast
72205-200	Roflumilast	Roflumilast
72205-201	Roflumilast	Roflumilast
80610-130	roflumilast	roflumilast