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United States · US · US:71205-828_1d438989-6431-4c62-8f24-444475d423a3

FENOPROFEN CALCIUM

Orange BookUNIISPLATC M01AE04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM01AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120582830
    30 CAPSULE in 1 BOTTLE (71205-828-30)
  • ndc11
    7120582860
    60 CAPSULE in 1 BOTTLE (71205-828-60)
  • ndc11
    7120582890
    90 CAPSULE in 1 BOTTLE (71205-828-90)

Annotations

UNII (FDA Substance ID)
0X2CW1QABJ
FENOPROFEN CALCIUM
RxCUI 267171
Orange Book
A214475
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": "71205-828_1d438989-6431-4c62-8f24-444475d423a3",
  "productndc": "71205-828",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214475",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 400MG BASE",
        "product_no": "001",
        "approval_date": "Jul 18, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 300MG BASE",
        "product_no": "003",
        "approval_date": "Jul 26, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOPROFEN CALCIUM",
  "proprietary_name": "FENOPROFEN CALCIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214475",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FENOPROFEN CALCIUM",
  "start_marketing_date": "20220801",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code M01AE04.

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