levothyroxine sodium

Generic: levothyroxine sodium anhydrous

Labeler: onesource specialty pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 100 ug/5mL

Manufacturer
ONESOURCE SPECIALTY PHARMA LIMITED

Identifiers & Regulatory

Product NDC 83270-006
Product ID 83270-006_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 83270006
Hyphenated Format 83270-006

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
  • 100 ug/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83270-006-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83270-006-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83270-006-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levothyroxine sodium anhydrous (100 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 (83270-006-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83270-006-01", "marketing_start_date": "20250930"}], "brand_name": "Levothyroxine Sodium", "product_id": "83270-006_35b79b8a-71ee-374b-e063-6394a90a887a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "83270-006", "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": "100 ug/5mL"}], "application_number": "ANDA216729", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}