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
6332364710
1 VIAL, SINGLE-DOSE in 1 CARTON (63323-647-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

054I36CPMN

LEVOTHYROXINE SODIUM ANHYDROUS

RxCUI 1372638

Orange Book

N202231

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Levothyroxine Sodium Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "054I36CPMN",
    "rxcui": "1372638",
    "inchikey": "YDTFRJLNMPSCFM-YDALLXLXSA-M",
    "display_name": "LEVOTHYROXINE SODIUM ANHYDROUS",
    "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": "63323-647_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea",
  "productndc": "63323-647",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202231",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MCG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 24, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "200MCG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 24, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MCG/VIAL",
        "product_no": "003",
        "approval_date": "Jun 24, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOTHYROXINE SODIUM ANHYDROUS",
  "shortage_reason": "Levothyroxine Sodium Tablet",
  "shortage_status": "current",
  "proprietary_name": "Levothyroxine Sodium",
  "active_ingred_unit": "ug/5mL",
  "application_number": "NDA202231",
  "marketing_category": "NDA",
  "nonproprietary_name": "LEVOTHYROXINE SODIUM ANHYDROUS",
  "start_marketing_date": "20110624",
  "active_numerator_strength": "200"
}

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