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United States · US · US:59746-801_aaa81c1b-f63d-4e61-8bfa-9d42d92043c7
Roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJubilant Cadista Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11597468017028 TABLET in 1 BLISTER PACK (59746-801-70)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208236
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": "59746-801_aaa81c1b-f63d-4e61-8bfa-9d42d92043c7",
"productndc": "59746-801",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208236",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Oct 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "002",
"approval_date": "Oct 19, 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": "ANDA208236",
"marketing_category": "ANDA",
"nonproprietary_name": "roflumilast",
"start_marketing_date": "20260202",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code R03DX07.
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