Polyethylene Glycol-3350 and Electrolytes with Flavor Pack is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Sodium Sulfate Anhydrous.
| Product ID | 40032-060_b76cfbc2-2ecf-478c-adae-a141ec93553d |
| NDC | 40032-060 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Polyethylene Glycol-3350 and Electrolytes with Flavor Pack |
| Generic Name | Polyethylene Glycol-3350 And Electrolytes With Flavor Pack |
| Dosage Form | Powder, For Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-06-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090186 |
| Labeler Name | Novel Laboratories, Inc. |
| Substance Name | POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS |
| Active Ingredient Strength | 240 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g |
| Pharm 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],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 |
| Marketing Start Date | 2009-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090186 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-06-01 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 3350 | 240 g/278.26g |
| SPL SET ID: | bf8925e7-6ea6-448c-810d-6f0d99127896 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 40032-060 | Polyethylene Glycol-3350 and Electrolytes with Flavor Pack | Polyethylene Glycol-3350 and Electrolytes with Flavor Pack |
| 43386-060 | GaviLyte - C | polyethylene glycol-3350 and electrolytes with Flavor Pack |