Synthroid

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerAbbVie Inc.

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0074659419
1000 TABLET in 1 BOTTLE (0074-6594-19)
ndc11
0074659472
2 BLISTER PACK in 1 CARTON (0074-6594-72) / 7 TABLET in 1 BLISTER PACK
ndc11
0074659490
90 TABLET in 1 BOTTLE (0074-6594-90)

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

N021402

AB1,AB2AB1,AB2AB1,AB2AB1,AB2AB1,AB2AB1,AB2AB1,AB2AB1,AB2

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": {
    "1e11ad30-1041-4520-10b0-8f9d30d30fcc": {
      "match": "brand_token",
      "title": "SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [ABBVIE INC.]",
      "spl_version": "1537",
      "published_date": "2024-02-29"
    }
  },
  "productid": "0074-6594_b85ab7fa-ba96-43cd-b736-44b3924e644c",
  "productndc": "0074-6594",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021402",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "001",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "002",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "003",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "004",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "005",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "006",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "007",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "008",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "009",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "010",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "011",
        "approval_date": "Jul 24, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1,AB2",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "012",
        "approval_date": "Jul 24, 2002"
      }
    ],
    "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": "Synthroid",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021402",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20020724",
  "active_numerator_strength": "88"
}

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