Over-the-counter drug · UNAPPROVED DRUG OTHER
Quabic-300 NDC 81943-502
hemodialysis grade sodium bicarbonate solution · Sodium bicarbonate 8.4 g/100mL · Solution, Concentrate · Hemodialysis · Aqua Medica, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81943-502-01 | 81943050201 | 3785 mL in 1 BOTTLE (81943-502-01)Marketed from Mar 30, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Quabic-300
- Generic name (nonproprietary)
- hemodialysis grade sodium bicarbonate solution
- Active ingredients
- Sodium bicarbonate — 8.4 g/100mL
- Dosage form
- Solution, Concentrate
- Route
- Hemodialysis
- Labeler
- Aqua Medica, S.A. de C.V.NDC labeler code 81943
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)
- Identifiers
- Product ID 81943-502_43487973-549d-9af0-e063-6294a90a8e92SPL ID 43487973-549d-9af0-e063-6294a90a8e92SPL set ID c3cd7f0f-8d70-23af-e053-2a95a90a569bUNII 8MDF5V39QO
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N481943050201followed by a unit qualifier and the quantityPackage 81943-0502-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use 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.
Excerpt only. Read the full label for complete information.
About NDC 81943-502
- What is NDC 81943-502?
- 81943-502 is the product NDC for Quabic-300, Sodium bicarbonate 8.4 g/100mL solution, concentrate, listed with the FDA by Aqua Medica, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quabic-300 (Hemodialysis Grade Sodium Bicarbonate Solution).
- What is the active ingredient?
- Sodium bicarbonate.
- Who is the labeler?
- Aqua Medica, S.A. de C.V., NDC labeler code 81943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quabic-300?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.