NDC 63323-180

Pyridoxine Hydrochloride

Pyridoxine Hydrochloride

Pyridoxine Hydrochloride 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 Pyridoxine Hydrochloride.

Product ID63323-180_969dd6dd-de7a-9b65-e053-2a95a90aaa5e
NDC63323-180
Product TypeHuman Prescription Drug
Proprietary NamePyridoxine Hydrochloride
Generic NamePyridoxine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1972-08-14
Marketing CategoryANDA / ANDA
Application NumberANDA080618
Labeler NameFresenius Kabi USA, LLC
Substance NamePYRIDOXINE HYDROCHLORIDE
Active Ingredient Strength100 mg/mL
Pharm ClassesVitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-180-01

25 VIAL in 1 TRAY (63323-180-01) > 1 mL in 1 VIAL (63323-180-00)
Marketing Start Date2000-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-180-01 [63323018001]

Pyridoxine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-05

NDC 63323-180-00 [63323018000]

Pyridoxine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-05

Drug Details

Active Ingredients

IngredientStrength
PYRIDOXINE HYDROCHLORIDE100 mg/mL

OpenFDA Data

SPL SET ID:a56d11c0-b033-4201-85ff-fc710506481a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312736
  • Pharmacological Class

    • Vitamin B6 Analog [EPC]
    • Vitamin B 6 [Chemical/Ingredient]
    • Analogs/Derivatives [Chemical/Ingredient]

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