🇺🇸
United States · US · US:0276-0503_4fa9e651-402e-420b-e063-6294a90a7dc3
Fenoprofen Calcium
Orange BookUNIISPLATC M01AE04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMisemer Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM01AE04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11027605039090 CAPSULE in 1 BOTTLE (0276-0503-90)
Annotations
UNII (FDA Substance ID)
0X2CW1QABJ
FENOPROFEN CALCIUM
RxCUI 267171
Orange Book
N017604
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0X2CW1QABJ",
"rxcui": "267171",
"inchikey": "LZPBLUATTGKZBH-UHFFFAOYSA-L",
"display_name": "FENOPROFEN CALCIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b26c8351-a955-4685-adad-a7233db39d92": {
"match": "brand_token",
"title": "FENOPROFEN CALCIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC]",
"spl_version": "1",
"published_date": "2026-05-20"
}
},
"productid": "0276-0503_4fa9e651-402e-420b-e063-6294a90a7dc3",
"productndc": "0276-0503",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "017604",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Jul 21, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOPROFEN CALCIUM",
"proprietary_name": "Fenoprofen Calcium",
"active_ingred_unit": "mg/1",
"application_number": "NDA017604",
"marketing_category": "NDA",
"nonproprietary_name": "Fenoprofen Calcium",
"start_marketing_date": "20211101",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code M01AE04.
- 🇺🇸Fenoprofen calciumAtland Pharmaceuticals, LLC
- 🇺🇸Fenoprofen CalciumMisemer Pharmaceuticals, Inc.
- 🇺🇸Fenoprofen CalciumMisemer Pharmaceuticals, Inc.
- 🇺🇸FENOPROFEN CALCIUMRising Pharma Holdings, Inc.
- 🇺🇸FENOPROFEN CALCIUMRising Pharma Holdings, Inc.
- 🇺🇸FENOPROFEN CALCIUMAtland Pharmaceuticals, LLC
- 🇺🇸FENOPROFEN CALCIUMRising Pharma Holdings, Inc.
- 🇺🇸FENOPROFEN CALCIUMProficient Rx LP
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