QUABIC-100

Manufacturer: Aqua Medica, S.A. de C.V.
Effective date: 2025-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:43:05

Label at a glance#

ProductQUABIC-100

Active ingredientSODIUM BICARBONATE

Label structure12 sections

Storage and handling

Keep at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/L

Each 1000 mL of this solution conteins:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

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

OTC - ACTIVE INGREDIENT SECTION

Sodium Bicarbonate: Antiseptic

OTC - PURPOSE SECTION

For use only with 3-pump hemodialysis machines.

INDICATIONS & USAGE SECTION

Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1

WARNINGS SECTION

This 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.

OTC - DO NOT USE SECTION

If cloudy or with borken seal.

OTC - WHEN USING SECTION

If not all 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.

STORAGE AND HANDLING SECTION

Keep at room temperature.

INACTIVE INGREDIENT SECTION

Purified water (standard ISO 13959:2014)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81943-503-03 500 g 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
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81943-503-03	QUABIC-100	500 mL in 1 BOTTLE	SOLUTION, CONCENTRATE	500		2

Products#

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

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

QUABIC-100
Hemodialysis Grade Sodium Bicarbonate Solution
SODIUM BICARBONATE
BICARBONATE ION
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81943-503	81943-503-03

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
SODIUM BICARBONATE	8MDF5V39QO	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2024-11-29	full-release	2026-06-01 00:39:50

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUABIC-100	HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION	Aqua Medica, S.A. de C.V.	1484a825-40c6-a9c9-e063-6294a90a9ca4	2025-11-10	Warnings	Exact identifier ndc (product): 81943-503
QUABIC-100	HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION	Aqua Medica, S.A. de C.V.	28152c9f-b15c-3707-e063-6394a90a70e9	2025-11-10	Warnings	Exact identifier ndc (package): 81943-503-03 ndc (product): 81943-503 ndc11 (package): 81943050303 spl id: 4348680b-9585-6674-e063-6294a90a5790 spl set id: 28152c9f-b15c-3707-e063-6394a90a70e9

Reported adverse events (FAERS/openFDA)#

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