QUABIC-300

Manufacturer: Aqua Medica, S.A. de C.V.
Effective date: 2025-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:43:12

Label at a glance#

ProductQUABIC-300

Active ingredientSODIUM BICARBONATE

Label structure13 sections

Storage and handling

Keep at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/l

Bicarbonate: 35.0 mEq/l

Each 1000 mL of this solution contains:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard ISO 13959:2014), csp: 1000 mL

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Bicarbonate: Antiseptic

Purpose

OTC - PURPOSE SECTION

For use only with 3-pump hemodialysis machines.

Use

INDICATIONS & USAGE SECTION

Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

Warnings

WARNINGS SECTION

The solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

DOSAGE & ADMINISTRATION SECTION

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

Do not use

OTC - DO NOT USE SECTION

If cloudy or with broken seal.

OTC - WHEN USING SECTION

If not all of the contents are used, discard the excess.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other information

STORAGE AND HANDLING SECTION

Keep at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water (standard ISO 13959:2014)

RECENT MAJOR CHANGES SECTION

Use only with 3-pump hemodialysis machines.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 81943-502-01 3785 mL Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BICARBONATE ION Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81943-502-01	2024-11-18	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b
81943-502-01	2024-11-18	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b
81943-502-01	2024-07-30	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b
81943-502-01	2024-07-30	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b
81943-502-01	2024-01-30	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b
81943-502-01	2024-01-30	C162847	48780-1	1030e365-35d9-111a-e063-dadaa90a10e2	c3cd7f0f-8d70-23af-e053-2a95a90a569b

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

QUABIC-300
Hemodialysis Grade Sodium Bicarbonate Solution
WATER
SODIUM BICARBONATE
BICARBONATE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81943-502	81943-502-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM BICARBONATE	8MDF5V39QO	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2024-11-18	full-release	2026-06-01 00:37:51

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUABIC-300	HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION	Aqua Medica, S.A. de C.V.	c3cd7f0f-8d70-23af-e053-2a95a90a569b	2025-11-10	Warnings	Exact identifier ndc (package): 81943-502-01 ndc (product): 81943-502 ndc11 (package): 81943050201 spl id: 43487973-549d-9af0-e063-6294a90a8e92 spl set id: c3cd7f0f-8d70-23af-e053-2a95a90a569b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.