levothyroxine sodium (83270-008)

Drug Facts

Product Profile

Brand Name levothyroxine sodium

Generic Name levothyroxine sodium anhydrous

Labeler onesource specialty pharma limited

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

levothyroxine sodium anhydrous 500 ug/5mL

Manufacturer

ONESOURCE SPECIALTY PHARMA LIMITED

Identifiers & Regulatory

Product NDC 83270-008

Product ID 83270-008_35b79b8a-71ee-374b-e063-6394a90a887a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216729

Listing Expiration 2026-12-31

Marketing Start 2025-08-15

Pharmacologic Class

Classes

thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83270008

Hyphenated Format 83270-008

Supplemental Identifiers

RxCUI

966219 1115267 1115269

UPC

0383270006010 0383270007017 0383270008014

UNII

054I36CPMN

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 anhydrous (source: ndc)

Application Number ANDA216729 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

500 ug/5mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (83270-008-01) / 5 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (1)

83270-008-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83270-008-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levothyroxine sodium anhydrous (500 ug/5mL)

Linked Drug Pages (1)

Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "35b79b8a-71ee-374b-e063-6394a90a887a", "openfda": {"upc": ["0383270006010", "0383270007017", "0383270008014"], "unii": ["054I36CPMN"], "rxcui": ["966219", "1115267", "1115269"], "spl_set_id": ["ae9954a5-e196-449c-abea-ebe4afbee517"], "manufacturer_name": ["ONESOURCE SPECIALTY PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83270-008-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83270-008-01", "marketing_start_date": "20250930"}], "brand_name": "Levothyroxine Sodium", "product_id": "83270-008_35b79b8a-71ee-374b-e063-6394a90a887a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "83270-008", "generic_name": "LEVOTHYROXINE SODIUM ANHYDROUS", "labeler_name": "ONESOURCE SPECIALTY PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM ANHYDROUS", "strength": "500 ug/5mL"}], "application_number": "ANDA216729", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}