Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2420100201
1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

N214253

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": "INTRAVENOUS",
  "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": "24201-002_563fecaf-128d-4f6b-81c8-715b4d90a261",
  "productndc": "24201-002",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214253",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MCG/ML",
        "product_no": "001",
        "approval_date": "May 17, 2021"
      }
    ],
    "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/mL",
  "application_number": "NDA214253",
  "marketing_category": "NDA",
  "nonproprietary_name": "LEVOTHYROXINE SODIUM",
  "start_marketing_date": "20221115",
  "active_numerator_strength": "100"
}

Related drugs

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