levothyroxine sodium

Generic: levothyroxine sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 200 ug/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-557
Product ID 59651-557_c760d0cc-2245-4914-8c67-d536c41ac90f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216414
Listing Expiration 2026-12-31
Marketing Start 2024-07-16

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651557
Hyphenated Format 59651-557

Supplemental Identifiers

RxCUI
892251 892255 966225 966249 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 ANDA216414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (59651-557-90)
  • 1000 TABLET in 1 BOTTLE (59651-557-99)
source: ndc

Packages (2)

59651-557-90 90 TABLET in 1 BOTTLE (59651-557-90) 59651-557-99 1000 TABLET in 1 BOTTLE (59651-557-99)

Ingredients (1)

levothyroxine sodium (200 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": "c760d0cc-2245-4914-8c67-d536c41ac90f", "openfda": {"unii": ["9J765S329G"], "rxcui": ["892251", "892255", "966225", "966249", "966270"], "spl_set_id": ["c760d0cc-2245-4914-8c67-d536c41ac90f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (59651-557-90)", "package_ndc": "59651-557-90", "marketing_start_date": "20240716"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-557-99)", "package_ndc": "59651-557-99", "marketing_start_date": "20240716"}], "brand_name": "Levothyroxine Sodium", "product_id": "59651-557_c760d0cc-2245-4914-8c67-d536c41ac90f", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "59651-557", "generic_name": "Levothyroxine Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "200 ug/1"}], "application_number": "ANDA216414", "marketing_category": "ANDA", "marketing_start_date": "20240716", "listing_expiration_date": "20261231"}