Levothyroxine sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1672945515
90 TABLET in 1 BOTTLE (16729-455-15)
ndc11
1672945517
1000 TABLET in 1 BOTTLE (16729-455-17)

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

A212399

AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4AB1,AB2,AB3,AB4

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": "16729-455_415fc774-31a5-124f-e063-6294a90a0e46",
  "productndc": "16729-455",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212399",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "001",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "002",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "003",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "004",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "005",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "006",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "007",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "008",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "009",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "010",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "011",
        "approval_date": "Oct 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "012",
        "approval_date": "Oct 19, 2020"
      }
    ],
    "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": "ug/1",
  "application_number": "ANDA212399",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20201125",
  "active_numerator_strength": "150"
}

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