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United States · US · US:59651-557_c760d0cc-2245-4914-8c67-d536c41ac90f

Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeH03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965155790
    90 TABLET in 1 BOTTLE (59651-557-90)
  • ndc11
    5965155799
    1000 TABLET in 1 BOTTLE (59651-557-99)

Annotations

UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
A216414
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": "59651-557_c760d0cc-2245-4914-8c67-d536c41ac90f",
  "productndc": "59651-557",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216414",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.137MG",
        "product_no": "001",
        "approval_date": "Jul 16, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG",
        "product_no": "002",
        "approval_date": "Jul 16, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.175MG",
        "product_no": "003",
        "approval_date": "Jul 16, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.2MG",
        "product_no": "004",
        "approval_date": "Jul 16, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3MG",
        "product_no": "005",
        "approval_date": "Jul 16, 2024"
      }
    ],
    "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": "ug/1",
  "application_number": "ANDA216414",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20240716",
  "active_numerator_strength": "200"
}

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