levothyroxine sodium

Generic: levothyroxine sodium

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

Drug Facts

Product Profile

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

levothyroxine sodium 88 ug/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1807
Product ID 0378-1807_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076187
Listing Expiration 2026-12-31
Marketing Start 2002-11-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781807
Hyphenated Format 0378-1807

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966248 966249 966253 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 ANDA076187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 88 ug/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1807-10)
  • 90 TABLET in 1 BOTTLE, PLASTIC (0378-1807-77)
source: ndc

Packages (2)

0378-1807-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1807-10) 0378-1807-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-1807-77)

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": "ca193039-55b1-4a7e-aa67-c4bff4f9f5b0", "openfda": {"unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966248", "966249", "966253", "966270"], "spl_set_id": ["e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-1807-10)", "package_ndc": "0378-1807-10", "marketing_start_date": "20021101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0378-1807-77)", "package_ndc": "0378-1807-77", "marketing_start_date": "20160627"}], "brand_name": "Levothyroxine Sodium", "product_id": "0378-1807_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "0378-1807", "generic_name": "levothyroxine sodium", "labeler_name": "Mylan Pharmaceuticals 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": "20021101", "listing_expiration_date": "20261231"}