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United States · US · US:72305-150_8b98dc0b-b9fa-42eb-81a0-07b4679d9332

EUTHYROX

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerProvell Pharmaceuticals, LLC
CountryUS (United States)
ATC codeH03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7230515030
    2 BLISTER PACK in 1 CARTON (72305-150-30) / 15 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N021292
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Levothyroxine Sodium Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "9J765S329G",
    "rxcui": "40144",
    "inchikey": "JMHCCAYJTTWMCX-QWPJCUCISA-M",
    "display_name": "LEVOTHYROXINE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bc3c6830-ba68-4ba3-9896-a12d0ad0b275": {
      "match": "brand_token",
      "title": "EUTHYROX (LEVOTHYROXINE SODIUM) TABLET [PROVELL PHARMACEUTICALS, LLC]",
      "spl_version": "10",
      "published_date": "2026-02-06"
    }
  },
  "productid": "72305-150_8b98dc0b-b9fa-42eb-81a0-07b4679d9332",
  "productndc": "72305-150",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021292",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.025MG",
        "product_no": "001",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.05MG",
        "product_no": "002",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.075MG",
        "product_no": "003",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.088MG",
        "product_no": "004",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1MG",
        "product_no": "005",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.112MG",
        "product_no": "006",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.125MG",
        "product_no": "007",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.137MG",
        "product_no": "008",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG",
        "product_no": "009",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.175MG",
        "product_no": "010",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.2MG",
        "product_no": "011",
        "approval_date": "May 31, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3MG",
        "product_no": "012",
        "approval_date": "May 31, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOTHYROXINE SODIUM",
  "shortage_reason": "Levothyroxine Sodium Tablet",
  "shortage_status": "current",
  "proprietary_name": "EUTHYROX",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021292",
  "marketing_category": "NDA",
  "nonproprietary_name": "levothyroxine sodium",
  "start_marketing_date": "20181017",
  "active_numerator_strength": "150"
}

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