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United States · US · US:0310-0088_11cd495f-c5cf-4076-b69c-af202ec2a8a1
Daliresp
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103100088281 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK
- ndc11031000883910 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
N022522
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0P6C6ZOP5U",
"rxcui": "1091836",
"inchikey": "MNDBXUUTURYVHR-UHFFFAOYSA-N",
"display_name": "ROFLUMILAST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c9a1d0a8-581f-4f91-a2b8-f419192d0ebf": {
"match": "brand_token",
"title": "DALIRESP (ROFLUMILAST) TABLET [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "15",
"published_date": "2025-12-19"
}
},
"productid": "0310-0088_11cd495f-c5cf-4076-b69c-af202ec2a8a1",
"productndc": "0310-0088",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022522",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Feb 28, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "250MCG",
"product_no": "002",
"approval_date": "Jan 23, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "Daliresp",
"active_ingred_unit": "ug/1",
"application_number": "NDA022522",
"marketing_category": "NDA",
"nonproprietary_name": "roflumilast",
"start_marketing_date": "20150701",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code R03DX07.
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