NDC 63323-648

Levothyroxine Sodium

Levothyroxine Sodium Anhydrous

Levothyroxine Sodium is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Levothyroxine Sodium Anhydrous.

Product ID63323-648_2fb52aa0-d533-4029-9d1c-213b727171ca
NDC63323-648
Product TypeHuman Prescription Drug
Proprietary NameLevothyroxine Sodium
Generic NameLevothyroxine Sodium Anhydrous
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-06-24
Marketing CategoryNDA / NDA
Application NumberNDA202231
Labeler NameFresenius Kabi USA, LLC
Substance NameLEVOTHYROXINE SODIUM ANHYDROUS
Active Ingredient Strength500 ug/5mL
Pharm Classesl-Thyroxine [EPC],Thyroxine [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-648-94

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-648-94) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2011-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-648-94 [63323064894]

Levothyroxine Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA202231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-24

NDC 63323-648-10 [63323064810]

Levothyroxine Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA202231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-24

Drug Details

Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM ANHYDROUS500 ug/5mL

OpenFDA Data

SPL SET ID:152d071f-d4aa-46d2-b397-61c1cabdd86d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1115267
  • 966219
  • Pharmacological Class

    • l-Thyroxine [EPC]
    • Thyroxine [CS]

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

    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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