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United States · US · US:64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71
roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11643807860130 TABLET in 1 BOTTLE (64380-786-01)
- ndc11643807860590 TABLET in 1 BOTTLE (64380-786-05)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208247
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": {
"cb3781ff-5350-4f9a-b247-0b04eb0f2b92": {
"match": "brand_token",
"title": "ROFLUMILAST TABLET [AMICI PHARMA INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71",
"productndc": "64380-786",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208247",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Mar 30, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "002",
"approval_date": "Jun 20, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "roflumilast",
"active_ingred_unit": "ug/1",
"application_number": "ANDA208247",
"marketing_category": "ANDA",
"nonproprietary_name": "ROFLUMILAST",
"start_marketing_date": "20221013",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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