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 50 ug/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7698
Product ID 68788-7698_0a8d16fa-f48c-44c3-b0b4-5e16b7e59421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021116
Listing Expiration 2027-12-31
Marketing Start 2020-04-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887698
Hyphenated Format 68788-7698

Supplemental Identifiers

RxCUI
966221
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
  • 50 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-7698-3)
  • 90 TABLET in 1 BOTTLE (68788-7698-9)
source: ndc

Packages (2)

68788-7698-3 30 TABLET in 1 BOTTLE (68788-7698-3) 68788-7698-9 90 TABLET in 1 BOTTLE (68788-7698-9)

Ingredients (1)

levothyroxine sodium (50 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": "0a8d16fa-f48c-44c3-b0b4-5e16b7e59421", "openfda": {"unii": ["9J765S329G"], "rxcui": ["966221"], "spl_set_id": ["59a99739-2da5-46a7-8811-1169123bed9b"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-7698-3)", "package_ndc": "68788-7698-3", "marketing_start_date": "20200401"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-7698-9)", "package_ndc": "68788-7698-9", "marketing_start_date": "20200401"}], "brand_name": "levothyroxine sodium", "product_id": "68788-7698_0a8d16fa-f48c-44c3-b0b4-5e16b7e59421", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "68788-7698", "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": "50 ug/1"}], "application_number": "NDA021116", "marketing_category": "NDA", "marketing_start_date": "20200401", "listing_expiration_date": "20271231"}