NDC 63323-013

Thiamine

Thiamine Hydrochloride

Thiamine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Thiamine Hydrochloride.

Product ID63323-013_4739cdd2-8a24-4f67-9a9f-902e9c0f3457
NDC63323-013
Product TypeHuman Prescription Drug
Proprietary NameThiamine
Generic NameThiamine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2000-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA080556
Labeler NameFresenius Kabi USA, LLC
Substance NameTHIAMINE HYDROCHLORIDE
Active Ingredient Strength100 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-013-26

25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-26) > 2 mL in 1 VIAL, MULTI-DOSE (63323-013-41)
Marketing Start Date2000-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-013-09 [63323001309]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-01

NDC 63323-013-02 [63323001302]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-01

NDC 63323-013-41 [63323001341]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-26

NDC 63323-013-21 [63323001321]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 63323-013-26 [63323001326]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-01

NDC 63323-013-01 [63323001301]

Thiamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
THIAMINE HYDROCHLORIDE100 mg/mL

OpenFDA Data

SPL SET ID:c3c9db74-95d4-487c-90c3-c810786fbaec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313324
  • UPC Code
  • 0363323013097
  • Medicade Reported Pricing

    63323001302 THIAMINE 200 MG/2 ML VIAL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Thiamine" or generic name "Thiamine Hydrochloride"

    NDCBrand NameGeneric Name
    50090-4407ThiamineTHIAMINE HYDROCHLORIDE
    55154-9372ThiamineTHIAMINE HYDROCHLORIDE
    63323-013ThiamineTHIAMINE HYDROCHLORIDE
    0404-9963THIAMINE HYDROCHLORIDEthiamine hydrochloride
    0641-6228Thiamine HydrochlorideThiamine Hydrochloride
    25021-500thiamine hydrochloridethiamine hydrochloride
    50090-5407Thiamine Hydrochloridethiamine hydrochloride
    52584-196THIAMINE HYDROCHLORIDEthiamine hydrochloride
    55150-273Thiamine HydrochlorideThiamine Hydrochloride
    67457-196Thiamine Hydrochloridethiamine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.