AQUACETIC-30
- Product NDC
- 81943-801
- 11-digit product format
- 819430801
- Labeler code
- 81943
- Product ID
- 81943-801_43485fb0-f129-7198-e063-6294a90afcde
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cleaning Solution for Hemodialysis Machines
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- HEMODIALYSIS
- Labeler
- Aqua Medica, S.A. de C.V.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2023-03-30
- Substance
- CITRIC ACID MONOHYDRATE
- Active strength
- .3 g/100mL
- Pharmacologic classes
- Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AQUACETIC-30
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITRIC ACID MONOHYDRATE | .3 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2968PHW8QP |
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 |
|---|
| 81943-801-01 | AQUACETIC-30 | 3785 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 3785 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81943-801 | AQUACETIC-30 (CLEANING SOLUTION FOR HEMODIALYSIS MACHINES) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.] | 2 | Current NDC, 1 package rows | 20241120_040775ab-41bd-cd36-e063-6394a90a08aa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81943-801-01 | 81943080101 | 3785 mL in 1 BOTTLE (81943-801-01) | 3785 ml | 2023-03-30 | No | No | Historical |