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United States · US · US:47781-651_12e236b4-dc71-96ce-cdd3-7bede41b3f1c

levothyroxine sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerAlvogen, Inc.
CountryUS (United States)
ATC codeH03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4778165110
    1000 TABLET in 1 BOTTLE (47781-651-10)
  • ndc11
    4778165190
    90 TABLET in 1 BOTTLE (47781-651-90)

Annotations

UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N021116
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": "47781-651_12e236b4-dc71-96ce-cdd3-7bede41b3f1c",
  "productndc": "47781-651",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021116",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "007",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "008",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "009",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "010",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "011",
        "approval_date": "Oct 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2,AB3,AB4",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "012",
        "approval_date": "Dec 7, 2004"
      }
    ],
    "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": "NDA021116",
  "marketing_category": "NDA",
  "nonproprietary_name": "levothyroxine sodium",
  "start_marketing_date": "20190507",
  "active_numerator_strength": "100"
}

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