MIPLYFFA

Orange BookUNIISPLATC N07XX17

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

Identification

ManufacturerAcer Therapeutics Inc.

CountryUS (United States)

ATC codeN07XX17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7254219301
1 BOTTLE in 1 CARTON (72542-193-01) / 90 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

Q85FFY6179

ARIMOCLOMOL CITRATE

Orange Book

N214927

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Q85FFY6179",
    "rxcui": null,
    "inchikey": "XSENLDLUMVYRET-BTQNPOSSSA-N",
    "display_name": "ARIMOCLOMOL CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5feffc0e-453d-47fa-91dd-38d4952309bc": {
      "match": "brand_token",
      "title": "MIPLYFFA (ARIMOCLOMOL CITRATE) CAPSULE [ACER THERAPEUTICS INC.]",
      "spl_version": "5",
      "published_date": "2026-03-20"
    }
  },
  "productid": "72542-193_18850625-1a1d-4351-862e-5d46b08eb978",
  "productndc": "72542-193",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214927",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 47MG BASE",
        "product_no": "001",
        "approval_date": "Sep 20, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 62MG BASE",
        "product_no": "002",
        "approval_date": "Sep 20, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 93MG BASE",
        "product_no": "003",
        "approval_date": "Sep 20, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 124MG BASE",
        "product_no": "004",
        "approval_date": "Sep 20, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIMOCLOMOL CITRATE",
  "proprietary_name": "MIPLYFFA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214927",
  "marketing_category": "NDA",
  "nonproprietary_name": "arimoclomol citrate",
  "start_marketing_date": "20240920",
  "active_numerator_strength": "93"
}

Related drugs

Other records sharing ATC code N07XX17.

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