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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

  • ndc11
    0276050390
    90 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        "strength": "EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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        "strength": "EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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        "strength": "EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"
}

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