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United States · US · US:70771-1674_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
Roflumilast
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707711674330 TABLET in 1 BOTTLE (70771-1674-3)
- ndc11707711674990 TABLET in 1 BOTTLE (70771-1674-9)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
A208303
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": "70771-1674_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6",
"productndc": "70771-1674",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208303",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MCG",
"product_no": "001",
"approval_date": "Feb 10, 2022"
},
{
"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": "ANDA208303",
"marketing_category": "ANDA",
"nonproprietary_name": "Roflumilast",
"start_marketing_date": "20221003",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code R03DX07.
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