levothyroxine sodium

Generic: levothyroxine sodium

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium 25 ug/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-447
Product ID 16729-447_415fc774-31a5-124f-e063-6294a90a0e46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212399
Listing Expiration 2026-12-31
Marketing Start 2020-12-10

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729447
Hyphenated Format 16729-447

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966248 966249 966253 966270
UPC
0316729447157 0316729449151 0316729452151 0316729454155 0316729453158 0316729448154 0316729451154 0316729457156 0316729450157 0316729456159 0316729458153 0316729455152
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 ANDA212399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 ug/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16729-447-15)
  • 1000 TABLET in 1 BOTTLE (16729-447-17)
source: ndc

Packages (2)

16729-447-15 90 TABLET in 1 BOTTLE (16729-447-15) 16729-447-17 1000 TABLET in 1 BOTTLE (16729-447-17)

Ingredients (1)

levothyroxine sodium (25 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": "415fc774-31a5-124f-e063-6294a90a0e46", "openfda": {"upc": ["0316729447157", "0316729449151", "0316729452151", "0316729454155", "0316729453158", "0316729448154", "0316729451154", "0316729457156", "0316729450157", "0316729456159", "0316729458153", "0316729455152"], "unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966248", "966249", "966253", "966270"], "spl_set_id": ["a6233381-3043-4e9a-aaa6-a6b105e5142b"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16729-447-15)", "package_ndc": "16729-447-15", "marketing_start_date": "20201210"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16729-447-17)", "package_ndc": "16729-447-17", "marketing_start_date": "20201210"}], "brand_name": "Levothyroxine sodium", "product_id": "16729-447_415fc774-31a5-124f-e063-6294a90a0e46", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "16729-447", "generic_name": "Levothyroxine Sodium", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "25 ug/1"}], "application_number": "ANDA212399", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20261231"}