tirosint

Generic: levothyroxine sodium

Labeler: ibsa pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tirosint
Generic Name levothyroxine sodium
Labeler ibsa pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

levothyroxine sodium 62.5 ug/1

Manufacturer
IBSA Pharma Inc.

Identifiers & Regulatory

Product NDC 71858-0017
Product ID 71858-0017_2c23e4a0-0b55-30e6-e063-6294a90af05b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021924
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 718580017
Hyphenated Format 71858-0017

Supplemental Identifiers

RxCUI
905451 905453 905455 905457 905458 905460 905462 905464 966404 966405 966406 966407 966412 966413 966415 966417 966420 966423 966426 966434 1923047 1923049 1923050 1923052 2630738 2630740 2630742 2630744 2630746 2630748
UPC
0371858001540 0371858006040 0371858003049 0371858004541 0371858001045 0371858004046 0371858001243 0371858001748 0371858002042 0371858003544 0371858001342 0371858005043
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 tirosint (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA021924 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 62.5 ug/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (71858-0017-1) / 10 CAPSULE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (71858-0017-2) / 10 CAPSULE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (71858-0017-4) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

71858-0017-1 1 BLISTER PACK in 1 CARTON (71858-0017-1) / 10 CAPSULE in 1 BLISTER PACK 71858-0017-2 3 BLISTER PACK in 1 CARTON (71858-0017-2) / 10 CAPSULE in 1 BLISTER PACK 71858-0017-4 3 BLISTER PACK in 1 CARTON (71858-0017-4) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

levothyroxine sodium (62.5 ug/1)

Linked Drug Pages (1)

Tirosint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c23e4a0-0b55-30e6-e063-6294a90af05b", "openfda": {"upc": ["0371858001540", "0371858006040", "0371858003049", "0371858004541", "0371858001045", "0371858004046", "0371858001243", "0371858001748", "0371858002042", "0371858003544", "0371858001342", "0371858005043"], "unii": ["9J765S329G"], "rxcui": ["905451", "905453", "905455", "905457", "905458", "905460", "905462", "905464", "966404", "966405", "966406", "966407", "966412", "966413", "966415", "966417", "966420", "966423", "966426", "966434", "1923047", "1923049", "1923050", "1923052", "2630738", "2630740", "2630742", "2630744", "2630746", "2630748"], "spl_set_id": ["7a7ade79-0165-4e31-b84e-667416c00c7e"], "manufacturer_name": ["IBSA Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (71858-0017-1)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "71858-0017-1", "marketing_end_date": "20260722", "marketing_start_date": "20230301"}, {"sample": true, "description": "3 BLISTER PACK in 1 CARTON (71858-0017-2)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "71858-0017-2", "marketing_start_date": "20250824"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (71858-0017-4)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "71858-0017-4", "marketing_start_date": "20230301"}], "brand_name": "Tirosint", "product_id": "71858-0017_2c23e4a0-0b55-30e6-e063-6294a90af05b", "dosage_form": "CAPSULE", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "71858-0017", "generic_name": "levothyroxine sodium", "labeler_name": "IBSA Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tirosint", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "62.5 ug/1"}], "application_number": "NDA021924", "marketing_category": "NDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}