levothyroxine sodium

Generic: levothyroxine sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levothyroxine sodium 100 ug/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 24201-002
Product ID 24201-002_563fecaf-128d-4f6b-81c8-715b4d90a261
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214253
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24201002
Hyphenated Format 24201-002

Supplemental Identifiers

RxCUI
2621123
UNII
9J765S329G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levothyroxine sodium (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA214253 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

levothyroxine sodium (100 ug/mL)

Linked Drug Pages (1)

Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "563fecaf-128d-4f6b-81c8-715b4d90a261", "openfda": {"unii": ["9J765S329G"], "rxcui": ["2621123"], "spl_set_id": ["6279390b-ee61-4ef9-ac15-25537ca783c1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "24201-002-01", "marketing_start_date": "20221115"}], "brand_name": "Levothyroxine Sodium", "product_id": "24201-002_563fecaf-128d-4f6b-81c8-715b4d90a261", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "24201-002", "generic_name": "LEVOTHYROXINE SODIUM", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "100 ug/mL"}], "application_number": "NDA214253", "marketing_category": "NDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}