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United States · US · US:31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118
Roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11317226233030 TABLET in 1 BOTTLE (31722-623-30)
- ndc113172262332100 BLISTER PACK in 1 CARTON (31722-623-32) / 10 TABLET in 1 BLISTER PACK (31722-623-31)
- ndc11317226239090 TABLET in 1 BOTTLE (31722-623-90)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208213
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": "31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118",
"productndc": "31722-623",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208213",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Nov 23, 2018"
},
{
"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": "ANDA208213",
"marketing_category": "ANDA",
"nonproprietary_name": "Roflumilast",
"start_marketing_date": "20221015",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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