Storage and handling
Keep at room temperature.
QUABIC-100
- Manufacturer
- AQUA MEDICA, S.A. DE C.V.
- Effective date
- 2023-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:35
Label at a glance#
ProductQUABIC-100
Active ingredientSODIUM BICARBONATE
Label structure12 sections
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 wather (standard 13959:2014), provides:
Sodium: 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
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 wit acid conentrate for hemodialysis, diluting with purified water.
OTC - DO NOT USE SECTION
If cloudy or with broken 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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BICARBONATE ION Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20220121 |
DailyMed Product Concepts#
| 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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81943-503-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-18e8-111a-e063-dadaa90a10e2 | ee80b38c-e28a-0a65-e053-2995a90a4003 |
| 81943-503-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-18e8-111a-e063-dadaa90a10e2 | ee80b38c-e28a-0a65-e053-2995a90a4003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81943-503-01 | QUABIC-100 | 3785 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 3785 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- QUABIC-100
- Hemodialysis Grade Sodium Bicarbonate Solution
- WATER
- SODIUM BICARBONATE
- BICARBONATE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81943-503 | 81943-503-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | ACTIB |
Source Document#
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.
| 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 | 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 | 81943-503 |
| 090bda94-9272-99f0-e063-6294a90a396c | ee80b38c-e28a-0a65-e053-2995a90a4003 | 2023-10-31 | Warnings | 090bda94-9272-99f0-e063-6294a90a396c ee80b38c-e28a-0a65-e053-2995a90a4003 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.