Levothyroxine Sodium

In shortageOrange BookUNIISPLATC H03AA01

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

Identification

ManufacturerPiramal Critical Care, Inc.

CountryUS (United States)

ATC codeH03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6679420002
5 mL in 1 VIAL, SINGLE-USE (66794-200-02)

Annotations

UNII (FDA Substance ID)

054I36CPMN

LEVOTHYROXINE SODIUM ANHYDROUS

RxCUI 1372638

Orange Book

A206163

APAP

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": "66794-200_3f9e1bbc-d3e2-c795-e063-6394a90aecdf",
  "productndc": "66794-200",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206163",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MCG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MCG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA206163",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levothyroxine Sodium",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "100"
}

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