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United States · US · US:72205-200_b56e7d3f-9930-43fa-baf4-63f9cee750f2
Roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11722052000610 BLISTER PACK in 1 CARTON (72205-200-06) / 10 TABLET in 1 BLISTER PACK (72205-200-11)
- ndc11722052003030 TABLET in 1 BOTTLE (72205-200-30)
- ndc11722052009090 TABLET in 1 BOTTLE (72205-200-90)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208256
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": "72205-200_b56e7d3f-9930-43fa-baf4-63f9cee750f2",
"productndc": "72205-200",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208256",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "001",
"approval_date": "Sep 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "002",
"approval_date": "Sep 7, 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": "ANDA208256",
"marketing_category": "ANDA",
"nonproprietary_name": "Roflumilast",
"start_marketing_date": "20220907",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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