NDC 71858-0120

Tirosint SOL

Levothyroxine Sodium

Tirosint SOL is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Ibsa Pharma Inc.. The primary component is Levothyroxine Sodium.

• Product ID: 71858-0120_2e777fd5-0c00-4c96-962f-d489ddf9de35
• NDC: 71858-0120
• Product Type: Human Prescription Drug
• Proprietary Name: Tirosint SOL
• Generic Name: Levothyroxine Sodium
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA206977
• Labeler Name: IBSA Pharma Inc.
• Substance Name: LEVOTHYROXINE SODIUM
• Active Ingredient Strength: 75 ug/mL
• Pharm Classes: l-Thyroxine [EPC],Thyroxine [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71858-0120-1

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

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71858-0120-5 [71858012005]

Tirosint SOL SOLUTION

• Marketing Category: NDA
• Application Number: NDA206977
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-01

NDC 71858-0120-1 [71858012001]

Tirosint SOL SOLUTION

• Marketing Category: NDA
• Application Number: NDA206977
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-01

NDC 71858-0120-4 [71858012004]

Tirosint SOL SOLUTION

• Marketing Category: NDA
• Application Number: NDA206977
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
LEVOTHYROXINE SODIUM	75 ug/mL

OpenFDA Data

• SPL SET ID: 5d378add-f13d-40f2-99dc-0f2340ab44b7
• Manufacturer:
  • IBSA Pharma Inc.
• UNII:
  • 9J765S329G
• RxNorm Concept Unique ID - RxCUI:
  • 2056466
  • 2056508
  • 2056462
  • 2056502
  • 2056500
  • 2056468
  • 2056506
  • 2056504
  • 2056498
  • 2056494
  • 2056496
  • 2056490
  • 2056492
  • 2056476
  • 2056474
  • 2056472
  • 2056470
  • 2056510
  • 2056478
  • 2056488
  • 2056482
  • 2056480
  • 2056486
  • 2056484

Pharmacological Class

• l-Thyroxine [EPC]
• Thyroxine [CS]

NDC Crossover Matching brand name "Tirosint SOL" or generic name "Levothyroxine Sodium"

NDC	Brand Name	Generic Name
71858-0115	Tirosint SOL	Tirosint SOL
71858-0125	Tirosint SOL	Tirosint SOL
71858-0140	Tirosint SOL	Tirosint SOL
71858-0105	Tirosint SOL	Tirosint SOL
71858-0130	Tirosint SOL	Tirosint SOL
71858-0110	Tirosint SOL	Tirosint SOL
71858-0145	Tirosint SOL	Tirosint SOL
71858-0155	Tirosint SOL	Tirosint SOL
71858-0150	Tirosint SOL	Tirosint SOL
71858-0160	Tirosint SOL	Tirosint SOL
71858-0120	Tirosint SOL	Tirosint SOL
71858-0135	Tirosint SOL	Tirosint SOL
0074-3727	Synthroid	Levothyroxine Sodium
0074-4341	Synthroid	Levothyroxine Sodium
0074-4552	Synthroid	Levothyroxine Sodium
0074-5182	Synthroid	Levothyroxine Sodium
0074-6594	Synthroid	Levothyroxine Sodium
0074-6624	Synthroid	Levothyroxine Sodium
0074-7068	Synthroid	Levothyroxine Sodium
0074-7069	Synthroid	Levothyroxine Sodium