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United States · US · US:71335-1502_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf

levothyroxine sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeH03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133515021
    30 TABLET in 1 BOTTLE (71335-1502-1)
  • ndc11
    7133515022
    90 TABLET in 1 BOTTLE (71335-1502-2)
  • ndc11
    7133515023
    100 TABLET in 1 BOTTLE (71335-1502-3)
  • ndc11
    7133515024
    7 TABLET in 1 BOTTLE (71335-1502-4)
  • ndc11
    7133515025
    14 TABLET in 1 BOTTLE (71335-1502-5)
  • ndc11
    7133515026
    60 TABLET in 1 BOTTLE (71335-1502-6)
  • ndc11
    7133515027
    21 TABLET in 1 BOTTLE (71335-1502-7)
  • ndc11
    7133515028
    42 TABLET in 1 BOTTLE (71335-1502-8)

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": "71335-1502_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf",
  "productndc": "71335-1502",
  "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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "50"
}

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