NDC 0378-1803

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Levothyroxine Sodium.

• Product ID: 0378-1803_2600c168-e9bb-4aeb-b63c-194e40782cf8
• NDC: 0378-1803
• Product Type: Human Prescription Drug
• Proprietary Name: Levothyroxine Sodium
• Generic Name: Levothyroxine Sodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2002-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076187
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: LEVOTHYROXINE SODIUM
• Active Ingredient Strength: 50 ug/1
• Pharm Classes: l-Thyroxine [EPC],Thyroxine [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0378-1803-04

1000 TABLET in 1 BOTTLE, PLASTIC (0378-1803-04)

• Marketing Start Date: 2020-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-1803-10 [00378180310]

Levothyroxine Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA076187
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-11-01

NDC 0378-1803-77 [00378180377]

Levothyroxine Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA076187
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-28

NDC 0378-1803-01 [00378180301]

Levothyroxine Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA076187
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-11-01
• Marketing End Date: 2017-08-31

Drug Details

Active Ingredients

Ingredient	Strength
LEVOTHYROXINE SODIUM	50 ug/1

OpenFDA Data

• SPL SET ID: e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 9J765S329G
• RxNorm Concept Unique ID - RxCUI:
  • 892255
  • 892246
  • 966253
  • 966249
  • 966248
  • 966225
  • 966224
  • 966221
  • 966220
  • 966222
  • 966270
  • 892251
• UPC Code:
  • 0303781811101
  • 0303781803779
  • 0303781805773

Pharmacological Class

• l-Thyroxine [EPC]
• Thyroxine [CS]

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

NDC	Brand Name	Generic Name
68071-3021	Levothyroxine sodium	Levothyroxine sodium
68071-4194	Levothyroxine sodium	Levothyroxine sodium
68071-4202	Levothyroxine sodium	Levothyroxine sodium
68071-4714	Levothyroxine Sodium	Levothyroxine Sodium
68071-4719	Levothyroxine sodium	Levothyroxine sodium
68071-4709	Levothyroxine Sodium	Levothyroxine Sodium
68071-4731	Levothyroxine Sodium	Levothyroxine Sodium
68071-4624	Levothyroxine sodium	Levothyroxine sodium
68071-4626	Levothyroxine Sodium	Levothyroxine Sodium
68071-4735	Levothyroxine Sodium	Levothyroxine Sodium
68071-4625	Levothyroxine sodium	Levothyroxine sodium
68180-971	Levothyroxine Sodium	Levothyroxine Sodium
68180-966	Levothyroxine Sodium	Levothyroxine Sodium
68180-975	Levothyroxine Sodium	Levothyroxine Sodium
68180-969	Levothyroxine Sodium	Levothyroxine Sodium
68180-968	Levothyroxine Sodium	Levothyroxine Sodium
68180-976	Levothyroxine Sodium	Levothyroxine Sodium
68180-965	Levothyroxine Sodium	Levothyroxine Sodium
68180-967	Levothyroxine Sodium	Levothyroxine Sodium
68180-972	Levothyroxine Sodium	Levothyroxine Sodium
68180-974	Levothyroxine Sodium	Levothyroxine Sodium
68180-970	Levothyroxine Sodium	Levothyroxine Sodium
68180-973	Levothyroxine Sodium	Levothyroxine Sodium
68788-7081	Levothyroxine sodium	Levothyroxine sodium
68788-7279	Levothyroxine Sodium	Levothyroxine Sodium
68788-6353	Levothyroxine sodium	Levothyroxine sodium
68788-7233	Levothyroxine Sodium	Levothyroxine Sodium
68788-7352	Levothyroxine Sodium	Levothyroxine Sodium
68788-7026	Levothyroxine sodium	Levothyroxine sodium
68788-9156	Levothyroxine Sodium	Levothyroxine Sodium
68788-9163	Levothyroxine Sodium	Levothyroxine Sodium
68788-7132	Levothyroxine Sodium	Levothyroxine Sodium
68788-7133	Levothyroxine Sodium	Levothyroxine Sodium
68788-6359	Levothyroxine sodium	Levothyroxine sodium
68788-9234	Levothyroxine sodium	Levothyroxine sodium
68788-7349	Levothyroxine sodium	Levothyroxine sodium
68788-7232	Levothyroxine sodium	Levothyroxine sodium
68788-7227	Levothyroxine Sodium	Levothyroxine Sodium
68788-7348	Levothyroxine Sodium	Levothyroxine Sodium
68788-9157	Levothyroxine Sodium	Levothyroxine Sodium
68788-9161	Levothyroxine Sodium	Levothyroxine Sodium
68788-9160	Levothyroxine Sodium	Levothyroxine Sodium
68788-9162	Levothyroxine Sodium	Levothyroxine Sodium
68788-9168	Levothyroxine Sodium	Levothyroxine Sodium
0527-1345	Levothyroxine Sodium	Levothyroxine Sodium
68788-9235	Levothyroxine sodium	Levothyroxine sodium
68788-9437	Levothyroxine Sodium	Levothyroxine Sodium
68788-9159	Levothyroxine Sodium	Levothyroxine Sodium
0527-1341	Levothyroxine Sodium	Levothyroxine Sodium
0527-1344	Levothyroxine Sodium	Levothyroxine Sodium