FENOPRON

Orange BookUNIISPLATC M01AE04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGalt Pharmaceuticals, LLC

CountryUS (United States)

ATC codeM01AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6182531110
100 CAPSULE in 1 BOTTLE (61825-311-10)

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": {
    "2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0": {
      "match": "brand_token",
      "title": "FENOPRON TM (FENOPROFEN CALCIUM) CAPSULE [GALT PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2026-02-27"
    }
  },
  "productid": "61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aa",
  "productndc": "61825-311",
  "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": "FENOPRON",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214475",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FENOPROFEN CALCIUM",
  "start_marketing_date": "20241210",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code M01AE04.

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