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United States · US · US:59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc
ROFLUMILAST
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11596512753030 TABLET in 1 BOTTLE (59651-275-30)
- ndc11596512759090 TABLET in 1 BOTTLE (59651-275-90)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A213298
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": "59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc",
"productndc": "59651-275",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213298",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Apr 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "002",
"approval_date": "Jan 31, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "ROFLUMILAST",
"active_ingred_unit": "ug/1",
"application_number": "ANDA213298",
"marketing_category": "ANDA",
"nonproprietary_name": "ROFLUMILAST",
"start_marketing_date": "20230417",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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