QUABIC-300
- Product NDC
- 81943-502
- 11-digit product format
- 819430502
- Labeler code
- 81943
- Product ID
- 81943-502_43487973-549d-9af0-e063-6294a90a8e92
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- QUABIC-300
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM BICARBONATE | 8.4 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8MDF5V39QO |
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 |
|---|
| 81943-502-01 | QUABIC-300 | 3785 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 3785 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81943-502 | QUABIC-300 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241120_c3cd7f0f-8d70-23af-e053-2a95a90a569b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81943-502-01 | 81943050201 | 3785 mL in 1 BOTTLE (81943-502-01) | 3785 ml | 2020-03-30 | 0000-00-00 | No | No | Current |