daliresp

Generic: roflumilast

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name daliresp
Generic Name roflumilast
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0095
Product ID 0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022522
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

Pharmacologic Class

Established (EPC)
phosphodiesterase 4 inhibitor [epc]
Mechanism of Action
phosphodiesterase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03100095
Hyphenated Format 0310-0095

Supplemental Identifiers

RxCUI
1091839 1091843 2001319 2001321
UNII
0P6C6ZOP5U
NUI
N0000182961 N0000182960

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name daliresp (source: ndc)
Generic Name roflumilast (source: ndc)
Application Number NDA022522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)
source: ndc

Packages (2)

0310-0095-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30) 0310-0095-90 90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)

Ingredients (1)

roflumilast (500 ug/1)

Linked Drug Pages (1)

Daliresp ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11cd495f-c5cf-4076-b69c-af202ec2a8a1", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "1091843", "2001319", "2001321"], "spl_set_id": ["c9a1d0a8-581f-4f91-a2b8-f419192d0ebf"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)", "package_ndc": "0310-0095-30", "marketing_start_date": "20150701"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)", "package_ndc": "0310-0095-90", "marketing_start_date": "20150701"}], "brand_name": "Daliresp", "product_id": "0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "0310-0095", "generic_name": "roflumilast", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daliresp", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "NDA022522", "marketing_category": "NDA", "marketing_start_date": "20150701", "listing_expiration_date": "20261231"}