Home NDC 81943-502-01 QUABIC-300
Product NDC 81943-502
Requested package NDC 81943-502-01
11-digit product format 819430502
Labeler code 81943
Product ID 81943-502_5dfd46ed-58bc-2015-e063-6394a90a8aec
Type HUMAN OTC DRUG
Nonproprietary name Hemodialysis Grade Sodium Bicarbonate Solution
Dosage form SOLUTION, CONCENTRATE
Route HEMODIALYSIS
Labeler Aqua Medica, S.A. de C.V.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-03-30
Substance SODIUM BICARBONATE
Active strength 8.4 g/100mL
Pharmacologic classes Alkalinizing Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 81943-502 81943-502-01 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 81943-502 81943-502-01 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base QUABIC-300
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM BICARBONATE 8.4 g/100mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81943-502-01 QUABIC-300 3785 mL in 1 BOTTLE SOLUTION, CONCENTRATE 3785 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81943-502 QUABIC-300 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] 7 Current NDC, Legacy NDC, 1 package rows 20241120_c3cd7f0f-8d70-23af-e053-2a95a90a569b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81943-502-01 81943050201 3785 mL in 1 BOTTLE (81943-502-01) 3785 ml 2020-03-30 0000-00-00 No No Current