levothyroxine sodium

Generic: levothyroxine sodium

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

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 25 ug/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8648
Product ID 68788-8648_bd78156a-c5ec-4686-8b61-d97bf0bafae0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021116
Listing Expiration 2026-12-31
Marketing Start 2024-05-03

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888648
Hyphenated Format 68788-8648

Supplemental Identifiers

RxCUI
966220
UNII
9J765S329G

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 NDA021116 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-8648-3)
  • 90 TABLET in 1 BOTTLE (68788-8648-9)
source: ndc

Packages (2)

68788-8648-3 30 TABLET in 1 BOTTLE (68788-8648-3) 68788-8648-9 90 TABLET in 1 BOTTLE (68788-8648-9)

Ingredients (1)

levothyroxine sodium (25 ug/1)

Linked Drug Pages (1)

levothyroxine sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bd78156a-c5ec-4686-8b61-d97bf0bafae0", "openfda": {"unii": ["9J765S329G"], "rxcui": ["966220"], "spl_set_id": ["412fc3f4-d9e0-49c5-b042-a6010aea7e5e"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8648-3)", "package_ndc": "68788-8648-3", "marketing_start_date": "20240503"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8648-9)", "package_ndc": "68788-8648-9", "marketing_start_date": "20240503"}], "brand_name": "levothyroxine sodium", "product_id": "68788-8648_bd78156a-c5ec-4686-8b61-d97bf0bafae0", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "68788-8648", "generic_name": "levothyroxine sodium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levothyroxine sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "25 ug/1"}], "application_number": "NDA021116", "marketing_category": "NDA", "marketing_start_date": "20240503", "listing_expiration_date": "20261231"}