levothyroxine sodium

Generic: levothyroxine sodium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 75 ug/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-053
Product ID 82804-053_89df6a0f-6602-4c22-a052-b565ea8368a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212399
Listing Expiration 2026-12-31
Marketing Start 2020-11-25

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804053
Hyphenated Format 82804-053

Supplemental Identifiers

RxCUI
966222
UPC
0382804053902
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 ANDA212399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-053-30)
  • 60 TABLET in 1 BOTTLE (82804-053-60)
  • 90 TABLET in 1 BOTTLE (82804-053-90)
source: ndc

Packages (3)

82804-053-30 30 TABLET in 1 BOTTLE (82804-053-30) 82804-053-60 60 TABLET in 1 BOTTLE (82804-053-60) 82804-053-90 90 TABLET in 1 BOTTLE (82804-053-90)

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": "89df6a0f-6602-4c22-a052-b565ea8368a7", "openfda": {"upc": ["0382804053902"], "unii": ["9J765S329G"], "rxcui": ["966222"], "spl_set_id": ["89df6a0f-6602-4c22-a052-b565ea8368a7"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-053-30)", "package_ndc": "82804-053-30", "marketing_start_date": "20231228"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-053-60)", "package_ndc": "82804-053-60", "marketing_start_date": "20231228"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-053-90)", "package_ndc": "82804-053-90", "marketing_start_date": "20231228"}], "brand_name": "Levothyroxine sodium", "product_id": "82804-053_89df6a0f-6602-4c22-a052-b565ea8368a7", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "82804-053", "generic_name": "Levothyroxine Sodium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "75 ug/1"}], "application_number": "ANDA212399", "marketing_category": "ANDA", "marketing_start_date": "20201125", "listing_expiration_date": "20261231"}