tirosint sol

Generic: levothyroxine sodium

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

Drug Facts

Product Profile

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

levothyroxine sodium 75 ug/mL

Manufacturer
IBSA Pharma Inc.

Identifiers & Regulatory

Product NDC 71858-0120
Product ID 71858-0120_2c23d44e-1a15-f636-e063-6294a90a0ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206977
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 718580120
Hyphenated Format 71858-0120

Supplemental Identifiers

RxCUI
2056462 2056466 2056468 2056470 2056472 2056474 2056476 2056478 2056480 2056482 2056484 2056486 2056488 2056490 2056492 2056494 2056496 2056498 2056500 2056502 2056504 2056506 2056508 2056510 2566608 2566610 2566613 2566615 2566617 2566619
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 sol (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA206977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 ug/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (71858-0120-2) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6)
  • 6 POUCH in 1 CARTON (71858-0120-5) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6)
source: ndc

Packages (2)

71858-0120-2 6 POUCH in 1 CARTON (71858-0120-2) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6) 71858-0120-5 6 POUCH in 1 CARTON (71858-0120-5) / 5 AMPULE in 1 POUCH (71858-0120-4) / 1 mL in 1 AMPULE (71858-0120-6)

Ingredients (1)

levothyroxine sodium (75 ug/mL)

Linked Drug Pages (1)

Tirosint SOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c23d44e-1a15-f636-e063-6294a90a0ed4", "openfda": {"unii": ["9J765S329G"], "rxcui": ["2056462", "2056466", "2056468", "2056470", "2056472", "2056474", "2056476", "2056478", "2056480", "2056482", "2056484", "2056486", "2056488", "2056490", "2056492", "2056494", "2056496", "2056498", "2056500", "2056502", "2056504", "2056506", "2056508", "2056510", "2566608", "2566610", "2566613", "2566615", "2566617", "2566619"], "spl_set_id": ["5d378add-f13d-40f2-99dc-0f2340ab44b7"], "manufacturer_name": ["IBSA Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "6 POUCH in 1 CARTON (71858-0120-2)  / 5 AMPULE in 1 POUCH (71858-0120-4)  / 1 mL in 1 AMPULE (71858-0120-6)", "package_ndc": "71858-0120-2", "marketing_start_date": "20250725"}, {"sample": false, "description": "6 POUCH in 1 CARTON (71858-0120-5)  / 5 AMPULE in 1 POUCH (71858-0120-4)  / 1 mL in 1 AMPULE (71858-0120-6)", "package_ndc": "71858-0120-5", "marketing_start_date": "20190301"}], "brand_name": "Tirosint SOL", "product_id": "71858-0120_2c23d44e-1a15-f636-e063-6294a90a0ed4", "dosage_form": "SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "71858-0120", "generic_name": "Levothyroxine Sodium", "labeler_name": "IBSA Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tirosint", "brand_name_suffix": "SOL", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "75 ug/mL"}], "application_number": "NDA206977", "marketing_category": "NDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}