levothyroxine sodium

Generic: levothyroxine sodium

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 75 ug/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-395
Product ID 33342-395_3a77ca51-7d8a-4755-aabc-3801cc772a10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211417
Listing Expiration 2026-12-31
Marketing Start 2022-12-21

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342395
Hyphenated Format 33342-395

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966248 966249 966253 966270
UPC
0333342393104 0333342397102 0333342404107 0333342393111 0333342400109 0333342403100 0333342393449 0333342394101 0333342402103 0333342396105 0333342395108 0333342398109 0333342399106
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 ANDA211417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 ug/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (33342-395-10)
  • 100 TABLET in 1 BOTTLE (33342-395-11)
  • 1000 TABLET in 1 BOTTLE (33342-395-44)
source: ndc

Packages (3)

33342-395-10 90 TABLET in 1 BOTTLE (33342-395-10) 33342-395-11 100 TABLET in 1 BOTTLE (33342-395-11) 33342-395-44 1000 TABLET in 1 BOTTLE (33342-395-44)

Ingredients (1)

levothyroxine sodium (75 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": "3a77ca51-7d8a-4755-aabc-3801cc772a10", "openfda": {"upc": ["0333342393104", "0333342397102", "0333342404107", "0333342393111", "0333342400109", "0333342403100", "0333342393449", "0333342394101", "0333342402103", "0333342396105", "0333342395108", "0333342398109", "0333342399106"], "unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966248", "966249", "966253", "966270"], "spl_set_id": ["b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-395-10)", "package_ndc": "33342-395-10", "marketing_start_date": "20221221"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-395-11)", "package_ndc": "33342-395-11", "marketing_start_date": "20221221"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (33342-395-44)", "package_ndc": "33342-395-44", "marketing_start_date": "20230124"}], "brand_name": "LEVOTHYROXINE SODIUM", "product_id": "33342-395_3a77ca51-7d8a-4755-aabc-3801cc772a10", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "33342-395", "generic_name": "LEVOTHYROXINE SODIUM", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOTHYROXINE SODIUM", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "75 ug/1"}], "application_number": "ANDA211417", "marketing_category": "ANDA", "marketing_start_date": "20221221", "listing_expiration_date": "20261231"}