levothyroxine sodium

Generic: levothyroxine sodium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 125 ug/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1612
Product ID 67046-1612_4302e10f-7a8b-1b53-e063-6294a90abfc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021342
Listing Expiration 2026-12-31
Marketing Start 2025-11-07

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461612
Hyphenated Format 67046-1612

Supplemental Identifiers

RxCUI
966224
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 NDA021342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1612-3)
source: ndc

Packages (1)

67046-1612-3 30 TABLET in 1 BLISTER PACK (67046-1612-3)

Ingredients (1)

levothyroxine sodium (125 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": "4302e10f-7a8b-1b53-e063-6294a90abfc0", "openfda": {"unii": ["9J765S329G"], "rxcui": ["966224"], "spl_set_id": ["4302e36f-0b5b-f645-e063-6394a90a010f"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1612-3)", "package_ndc": "67046-1612-3", "marketing_start_date": "20251107"}], "brand_name": "Levothyroxine Sodium", "product_id": "67046-1612_4302e10f-7a8b-1b53-e063-6294a90abfc0", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "67046-1612", "generic_name": "Levothyroxine Sodium", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "125 ug/1"}], "application_number": "NDA021342", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20251107", "listing_expiration_date": "20261231"}