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United States · US · US:42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc
ROFLUMILAST
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc114257136905500 TABLET in 1 BOTTLE (42571-369-05)
- ndc11425713691110 BLISTER PACK in 1 CARTON (42571-369-11) / 10 TABLET in 1 BLISTER PACK (42571-369-32)
- ndc11425713693030 TABLET in 1 BOTTLE (42571-369-30)
- ndc11425713698328 TABLET in 1 BOTTLE (42571-369-83)
- ndc11425713699090 TABLET in 1 BOTTLE (42571-369-90)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208180
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": "42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc",
"productndc": "42571-369",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208180",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Mar 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "002",
"approval_date": "Apr 18, 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": "ANDA208180",
"marketing_category": "ANDA",
"nonproprietary_name": "ROFLUMILAST",
"start_marketing_date": "20230501",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code R03DX07.
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