unithroid

Generic: levothyroxine sodium

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name unithroid
Generic Name levothyroxine sodium
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 50 ug/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 60846-802
Product ID 60846-802_35a7647b-9644-4c4c-8011-a0d5969c0a56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021210
Listing Expiration 2026-12-31
Marketing Start 2014-07-03

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60846802
Hyphenated Format 60846-802

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966228 966232 966233 966235 966237 966238 966241 966243 966244 966246 966248 966249 966253 966270 966286 966436
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 unithroid (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA021210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60846-802-01)
source: ndc

Packages (1)

60846-802-01 100 TABLET in 1 BOTTLE (60846-802-01)

Ingredients (1)

levothyroxine sodium (50 ug/1)

Linked Drug Pages (1)

Unithroid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35a7647b-9644-4c4c-8011-a0d5969c0a56", "openfda": {"unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966228", "966232", "966233", "966235", "966237", "966238", "966241", "966243", "966244", "966246", "966248", "966249", "966253", "966270", "966286", "966436"], "spl_set_id": ["07562e72-7eaa-4ce6-94f0-e08814787e50"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60846-802-01)", "package_ndc": "60846-802-01", "marketing_start_date": "20140703"}], "brand_name": "Unithroid", "product_id": "60846-802_35a7647b-9644-4c4c-8011-a0d5969c0a56", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "60846-802", "generic_name": "levothyroxine sodium", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Unithroid", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "50 ug/1"}], "application_number": "NDA021210", "marketing_category": "NDA", "marketing_start_date": "20140703", "listing_expiration_date": "20261231"}