Unithroid

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6084681201
100 TABLET in 1 BOTTLE (60846-812-01)

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

N021210

AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3AB1,AB2,AB3

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": {
    "07562e72-7eaa-4ce6-94f0-e08814787e50": {
      "match": "brand_token",
      "title": "UNITHROID (LEVOTHYROXINE SODIUM) TABLET [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "13",
      "published_date": "2024-02-16"
    }
  },
  "productid": "60846-812_35a7647b-9644-4c4c-8011-a0d5969c0a56",
  "productndc": "60846-812",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021210",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "001",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "002",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "003",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "004",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "005",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "006",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "007",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "008",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "009",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "010",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "011",
        "approval_date": "Aug 21, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "012",
        "approval_date": "Feb 8, 2008"
      }
    ],
    "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": "Unithroid",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021210",
  "marketing_category": "NDA",
  "nonproprietary_name": "levothyroxine sodium",
  "start_marketing_date": "20140703",
  "active_numerator_strength": "300"
}

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