Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5009049510
30 TABLET in 1 BOTTLE (50090-4951-0)
ndc11
5009049511
90 TABLET in 1 BOTTLE (50090-4951-1)

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

A209713

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": "50090-4951_4ba3b2b8-f1a9-4dd0-a88b-f0f7e7e91980",
  "productndc": "50090-4951",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209713",
    "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "Jan 18, 2019"
      },
      {
        "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": "008",
        "approval_date": "Jan 18, 2019"
      },
      {
        "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": "009",
        "approval_date": "Jan 18, 2019"
      },
      {
        "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": "010",
        "approval_date": "Jan 18, 2019"
      },
      {
        "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": "011",
        "approval_date": "Jan 18, 2019"
      },
      {
        "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": "012",
        "approval_date": "Jan 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "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": "mg/1",
  "application_number": "ANDA209713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20190320",
  "active_numerator_strength": ".088"
}

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