QUABIC-100
- Product NDC
- 81943-503
- Requested package NDC
- 81943-503-02
- 11-digit product format
- 819430503
- Labeler code
- 81943
- Product ID
- 81943-503_5dfd3c1e-4a17-46c9-e063-6294a90a2714
- 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
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-100
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM BICARBONATE | 8.4 g/100mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 8MDF5V39QO | Internal UNII lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
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 |
|---|
| 81943-503-01 | QUABIC-100 | 3785 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 3785 | | 2 |
| 81943-503-02 | QUABIC-100 | 650 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 650 | | 2 |
| 81943-503-03 | QUABIC-100 | 500 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81943-503 | QUABIC-100 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231101_ee80b38c-e28a-0a65-e053-2995a90a4003.zip |
| 81943-503 | QUABIC-100 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20241201_28152c9f-b15c-3707-e063-6394a90a70e9.zip |
| 81943-503 | QUABIC-100 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20241120_1484a825-40c6-a9c9-e063-6294a90a9ca4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81943-503-02 | 81943050302 | 650 mL in 1 BOTTLE (81943-503-02) | 650 ml | 2020-03-30 | No | No | Current |