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United States · US · US:65976-100_668385ee-9443-4d20-b0ea-655c2526ca96

Arestin

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerOraPharma, Inc.
CountryUS (United States)
ATC codeA01AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6597610001
    1 POWDER in 1 POUCH (65976-100-01)
  • ndc11
    6597610012
    1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
  • ndc11
    6597610024
    2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY

Annotations

UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
N050781
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": {
    "8515df41-1936-4f3b-86ba-d2bb2a8441fb": {
      "match": "brand_token",
      "title": "ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]",
      "spl_version": "21",
      "published_date": "2024-08-16"
    }
  },
  "productid": "65976-100_668385ee-9443-4d20-b0ea-655c2526ca96",
  "productndc": "65976-100",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "050781",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Feb 16, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MINOCYCLINE HYDROCHLORIDE",
  "proprietary_name": "Arestin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050781",
  "marketing_category": "NDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "20110321",
  "active_numerator_strength": "1"
}

Related drugs

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