NDC 81943-503

QUABIC-100

Hemodialysis Grade Sodium Bicarbonate Solution

QUABIC-100 is a Hemodialysis Solution, Concentrate in the Human Otc Drug category. It is labeled and distributed by Aqua Medica, S.a. De C.v.. The primary component is Sodium Bicarbonate.

Product ID81943-503_ee80b38c-e28b-0a65-e053-2995a90a4003
NDC81943-503
Product TypeHuman Otc Drug
Proprietary NameQUABIC-100
Generic NameHemodialysis Grade Sodium Bicarbonate Solution
Dosage FormSolution, Concentrate
Route of AdministrationHEMODIALYSIS
Marketing Start Date2020-03-30
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart356
Labeler NameAQUA MEDICA, S.A. DE C.V.
Substance NameSODIUM BICARBONATE
Active Ingredient Strength8 g/100mL
Pharm ClassesAlkalinizing Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81943-503-01

3785 mL in 1 BOTTLE (81943-503-01)
Marketing Start Date2020-03-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "QUABIC-100" or generic name "Hemodialysis Grade Sodium Bicarbonate Solution"

NDCBrand NameGeneric Name
81943-503QUABIC-100Hemodialysis Grade Sodium Bicarbonate Solution
81943-501Hemodialysis Grade Sodium Bicarbonate SolutionHemodialysis Grade Sodium Bicarbonate Solution
81943-502QUABIC-300Hemodialysis Grade Sodium Bicarbonate Solution

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