levothyroxine sodium

Generic: levothyroxine sodium

Labeler: lannett company, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler lannett company, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 112 ug/1

Manufacturer
Lannett Company, Inc

Identifiers & Regulatory

Product NDC 0527-3285
Product ID 0527-3285_47e50f93-a701-747e-e063-6294a90a5259
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021342
Listing Expiration 2027-12-31
Marketing Start 2020-08-03

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05273285
Hyphenated Format 0527-3285

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966248 966249 966253 966270
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 levothyroxine sodium (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA021342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 112 ug/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (0527-3285-43)
  • 90 TABLET in 1 BOTTLE (0527-3285-46)
source: ndc

Packages (2)

0527-3285-43 1000 TABLET in 1 BOTTLE (0527-3285-43) 0527-3285-46 90 TABLET in 1 BOTTLE (0527-3285-46)

Ingredients (1)

levothyroxine sodium (112 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": "47e50f93-a701-747e-e063-6294a90a5259", "openfda": {"unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966248", "966249", "966253", "966270"], "spl_set_id": ["a8db0f7d-8863-9309-e053-2995a90a284a"], "manufacturer_name": ["Lannett Company, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (0527-3285-43)", "package_ndc": "0527-3285-43", "marketing_start_date": "20200803"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0527-3285-46)", "package_ndc": "0527-3285-46", "marketing_start_date": "20200803"}], "brand_name": "Levothyroxine Sodium", "product_id": "0527-3285_47e50f93-a701-747e-e063-6294a90a5259", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "0527-3285", "generic_name": "Levothyroxine Sodium", "labeler_name": "Lannett Company, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "112 ug/1"}], "application_number": "NDA021342", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200803", "listing_expiration_date": "20271231"}