Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8280409930
30 TABLET in 1 BOTTLE (82804-099-30)
ndc11
8280409990
90 TABLET in 1 BOTTLE (82804-099-90)

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

N021342

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": {
    "5852d874-1ebc-49ff-b6c2-1dd513fca784": {
      "match": "brand_token",
      "title": "LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-28"
    }
  },
  "productid": "82804-099_9e69af45-d5a3-4986-8ea5-dee9e59272d7",
  "productndc": "82804-099",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021342",
    "products": [
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Mar 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "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": "Dec 8, 2003"
      }
    ],
    "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": "Levothyroxine Sodium",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021342",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20200803",
  "active_numerator_strength": "50"
}

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