quabic-300

Generic: hemodialysis grade sodium bicarbonate solution

Labeler: aqua medica, s.a. de c.v.
NDC Directory HUMAN OTC DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name quabic-300
Generic Name hemodialysis grade sodium bicarbonate solution
Labeler aqua medica, s.a. de c.v.
Dosage Form SOLUTION, CONCENTRATE
Routes
HEMODIALYSIS
Active Ingredients

sodium bicarbonate 8.4 g/100mL

Manufacturer
Aqua Medica, S.A. de C.V.

Identifiers & Regulatory

Product NDC 81943-502
Product ID 81943-502_43487973-549d-9af0-e063-6294a90a8e92
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2020-03-30

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81943502
Hyphenated Format 81943-502

Supplemental Identifiers

UNII
8MDF5V39QO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name quabic-300 (source: ndc)
Generic Name hemodialysis grade sodium bicarbonate solution (source: ndc)
Routes
HEMODIALYSIS
source: ndc

Resolved Composition

Strengths
  • 8.4 g/100mL
source: ndc
Packaging
  • 3785 mL in 1 BOTTLE (81943-502-01)
source: ndc

Packages (1)

81943-502-01 3785 mL in 1 BOTTLE (81943-502-01)

Ingredients (1)

sodium bicarbonate (8.4 g/100mL)

Linked Drug Pages (1)

QUABIC-300 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["HEMODIALYSIS"], "spl_id": "43487973-549d-9af0-e063-6294a90a8e92", "openfda": {"unii": ["8MDF5V39QO"], "spl_set_id": ["c3cd7f0f-8d70-23af-e053-2a95a90a569b"], "manufacturer_name": ["Aqua Medica, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3785 mL in 1 BOTTLE (81943-502-01)", "package_ndc": "81943-502-01", "marketing_start_date": "20200330"}], "brand_name": "QUABIC-300", "product_id": "81943-502_43487973-549d-9af0-e063-6294a90a8e92", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "81943-502", "generic_name": "Hemodialysis Grade Sodium Bicarbonate Solution", "labeler_name": "Aqua Medica, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "QUABIC-300", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "8.4 g/100mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20200330", "listing_expiration_date": "20261231"}