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United States · US · US:31722-288_7c79df0b-836b-479b-a7a6-8e09b802a84e

LEVOTHYROXINE SODIUM

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

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

Packs · 4

  • ndc11
    3172228801
    100 TABLET in 1 BOTTLE (31722-288-01)
  • ndc11
    3172228810
    1000 TABLET in 1 BOTTLE (31722-288-10)
  • ndc11
    3172228830
    30 TABLET in 1 BOTTLE (31722-288-30)
  • ndc11
    3172228890
    90 TABLET in 1 BOTTLE (31722-288-90)

Annotations

UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
A215259
AB4AB4AB4AB4AB4AB4AB4AB4
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": "31722-288_7c79df0b-836b-479b-a7a6-8e09b802a84e",
  "productndc": "31722-288",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215259",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "001",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "002",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "003",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "004",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "005",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "006",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "007",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "008",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "009",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "010",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "011",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium",
        "product_no": "012",
        "approval_date": "Jan 18, 2023"
      }
    ],
    "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": "mg/1",
  "application_number": "ANDA215259",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levothyroxine sodium",
  "start_marketing_date": "20230118",
  "active_numerator_strength": ".1"
}

Related drugs

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