Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332388514
1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-14) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

9J765S329G

LEVOTHYROXINE SODIUM

RxCUI 40144

Orange Book

N210632

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": "63323-885_6514086f-834b-4c0c-82a1-c95338ef42a0",
  "productndc": "63323-885",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210632",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MCG/5ML (20MCG/ML)",
        "product_no": "001",
        "approval_date": "Apr 11, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MCG/5ML (40MCG/ML)",
        "product_no": "002",
        "approval_date": "Apr 11, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MCG/5ML (100MCG/ML)",
        "product_no": "003",
        "approval_date": "Apr 11, 2019"
      }
    ],
    "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": "NDA210632",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20180529",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code H03AA01.

Access this data programmatically

Query Levothyroxine Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs