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United States · US · US:60793-858_e230c170-2a16-47d0-bce7-ac0414c192f7

LEVOXYL

In shortageOrange BookUNIIATC H03AA01

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeH03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6079385801
    100 TABLET in 1 BOTTLE (60793-858-01)
  • ndc11
    6079385810
    1000 TABLET in 1 BOTTLE (60793-858-10)

Annotations

UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N021301
AB1,AB3AB1,AB3AB1,AB3AB1,AB3AB1,AB3AB1,AB3AB1,AB3AB1,AB3
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",
  "productid": "60793-858_e230c170-2a16-47d0-bce7-ac0414c192f7",
  "productndc": "60793-858",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021301",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "001",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "002",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "003",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "004",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "005",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "006",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "007",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "008",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "009",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "010",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1,AB3",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "011",
        "approval_date": "May 25, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "012",
        "approval_date": "May 25, 2001"
      }
    ],
    "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": "LEVOXYL",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021301",
  "marketing_category": "NDA",
  "nonproprietary_name": "levothyroxine sodium",
  "start_marketing_date": "20010525",
  "active_numerator_strength": "150"
}

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