Home NDC 81943-801 AQUACETIC-30
Product NDC 81943-801
11-digit product format 819430801
Labeler code 81943
Product ID 81943-801_5dfd4a78-2c38-5454-e063-6294a90a4826
Type HUMAN OTC DRUG
Nonproprietary name Cleaning Solution for Hemodialysis Machines
Dosage form SOLUTION, CONCENTRATE
Route HEMODIALYSIS
Labeler Aqua Medica, S.A. de C.V.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-03-30
Substance CITRIC ACID MONOHYDRATE
Active strength .3 g/100mL
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 81943-801-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 81943-801-01 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 AQUACETIC-30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRIC ACID MONOHYDRATE .3 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 81943-801-01 AQUACETIC-30 3785 mL in 1 BOTTLE SOLUTION, CONCENTRATE 3785 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81943-801 AQUACETIC-30 (CLEANING SOLUTION FOR HEMODIALYSIS MACHINES) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] 2 Current NDC, 1 package rows 20241120_040775ab-41bd-cd36-e063-6394a90a08aa.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81943-801-01 81943080101 3785 mL in 1 BOTTLE (81943-801-01) 3785 ml 2023-03-30 No No Current