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United States · US · US:43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd
ROFLUMILAST
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US, LLC.
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435470050330 TABLET in 1 BOTTLE (43547-005-03)
- ndc11435470050990 TABLET in 1 BOTTLE (43547-005-09)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208299
AB
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": {
"cb3781ff-5350-4f9a-b247-0b04eb0f2b92": {
"match": "brand_token",
"title": "ROFLUMILAST TABLET [AMICI PHARMA INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd",
"productndc": "43547-005",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208299",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "May 10, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "ROFLUMILAST",
"active_ingred_unit": "ug/1",
"application_number": "ANDA208299",
"marketing_category": "ANDA",
"nonproprietary_name": "roflumilast",
"start_marketing_date": "20220510",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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