levothyroxine sodium

Generic: levothyroxine sodium

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler mylan institutional inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 88 ug/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 42292-038
Product ID 42292-038_3a991bf1-d9aa-b137-e063-6294a90af2cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076187
Listing Expiration 2026-12-31
Marketing Start 2017-01-18

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42292038
Hyphenated Format 42292-038

Supplemental Identifiers

RxCUI
966248 966249 966253 966270
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 ANDA076187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 88 ug/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (42292-038-20) / 1 TABLET in 1 BLISTER PACK (42292-038-01)
source: ndc

Packages (1)

42292-038-20 100 BLISTER PACK in 1 CARTON (42292-038-20) / 1 TABLET in 1 BLISTER PACK (42292-038-01)

Ingredients (1)

levothyroxine sodium (88 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": "3a991bf1-d9aa-b137-e063-6294a90af2cf", "openfda": {"unii": ["9J765S329G"], "rxcui": ["966248", "966249", "966253", "966270"], "spl_set_id": ["cd69c192-cd3f-47e6-b0a6-c536ffed5c4b"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42292-038-20)  / 1 TABLET in 1 BLISTER PACK (42292-038-01)", "package_ndc": "42292-038-20", "marketing_start_date": "20170118"}], "brand_name": "Levothyroxine Sodium", "product_id": "42292-038_3a991bf1-d9aa-b137-e063-6294a90af2cf", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "42292-038", "generic_name": "levothyroxine sodium", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "88 ug/1"}], "application_number": "ANDA076187", "marketing_category": "ANDA", "marketing_start_date": "20170118", "listing_expiration_date": "20261231"}