NDC 0378-1809

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 ID0378-1809_2600c168-e9bb-4aeb-b63c-194e40782cf8
NDC0378-1809
Product TypeHuman Prescription Drug
Proprietary NameLevothyroxine Sodium
Generic NameLevothyroxine Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA076187
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLEVOTHYROXINE SODIUM
Active Ingredient Strength100 ug/1
Pharm Classesl-Thyroxine [EPC],Thyroxine [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-1809-04

1000 TABLET in 1 BOTTLE, PLASTIC (0378-1809-04)
Marketing Start Date2020-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1809-01 [00378180901]

Levothyroxine Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076187
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01
Marketing End Date2017-08-31

NDC 0378-1809-10 [00378180910]

Levothyroxine Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076187
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01

NDC 0378-1809-77 [00378180977]

Levothyroxine Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076187
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-27

Drug Details

Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM100 ug/1

OpenFDA Data

SPL SET ID:e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc
Manufacturer
UNII
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"

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

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