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United States · US · US:69489-131_335d912c-9d84-1e78-e063-6294a90aa2f9

EMROSI

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerJourney Medical Corporation
CountryUS (United States)
ATC codeA01AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6948913107
    7 CAPSULE in 1 BOTTLE (69489-131-07)
  • ndc11
    6948913130
    30 CAPSULE in 1 BOTTLE (69489-131-30)

Annotations

UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
N219015
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0020414E5U",
    "rxcui": "6979",
    "inchikey": "GLMUAFMGXXHGLU-VQAITOIOSA-N",
    "display_name": "MINOCYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0899eb25-8807-037c-f66c-141a2696b1c0": {
      "match": "brand_token",
      "title": "EMROSI (MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE) CAPSULE [JOURNEY MEDICAL CORPORATION]",
      "spl_version": "5",
      "published_date": "2025-04-24"
    }
  },
  "productid": "69489-131_335d912c-9d84-1e78-e063-6294a90aa2f9",
  "productndc": "69489-131",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219015",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "001",
        "approval_date": "Nov 1, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MINOCYCLINE HYDROCHLORIDE",
  "proprietary_name": "EMROSI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219015",
  "marketing_category": "NDA",
  "nonproprietary_name": "Minocycline Hydrochloride Extended-Release",
  "start_marketing_date": "20250301",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A01AB23.

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