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United States · US · US:51407-975_30dd6be3-6f60-c6a9-e063-6294a90afaa4
Roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11514079759090 TABLET in 1 BOTTLE (51407-975-90)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A212490
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": "51407-975_30dd6be3-6f60-c6a9-e063-6294a90afaa4",
"productndc": "51407-975",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212490",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MCG",
"product_no": "001",
"approval_date": "Apr 18, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"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": "ANDA212490",
"marketing_category": "ANDA",
"nonproprietary_name": "Roflumilast",
"start_marketing_date": "20230418",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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