Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
- Product NDC
- 40032-050
- 11-digit product format
- 400320050
- Labeler code
- 40032
- Product ID
- 40032-050_0cb089b8-0127-4f5f-8b8d-77bc93409747
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA090019
- Marketing category
- ANDA
- Marketing start
- 2009-05-28
- Marketing end
- 0000-00-00
- Substance
- POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
- Active strength
- 420 g/438.4g; g/438.4g; g/438.4g; g/438.4g
- Pharmacologic classes
- Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40032-050-19 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c54c-621f-e053-dbdaa90a74ad | PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor pack |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40032-050-19 | Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate | 438.4 g in 1 BOTTLE | POWDER, FOR SOLUTION | 438.4 | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40032-050 | POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.] | 2 | Legacy NDC, 1 package rows | 20091119_444c83ae-ac3a-467c-be05-e2bcbfbaaba1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801054 | PEG-3350 420 GM / sodium chloride 11.2 GM / sodium bicarbonate 5.72 GM / potassium chloride 1.48 GM Powder for Oral Solution | PSN | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
| 801054 | polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution | SCD | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
| 801054 | PEG 3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM per 4 L Powder for Oral Solution | SY | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
| 801054 | PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution | SY | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 444c83ae-ac3a-467c-be05-e2bcbfbaaba1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 40032-050-19 | 40032005019 | 438.4 g in 1 BOTTLE | 438.4 g | Historical |