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NDC 43386-0050-19 GAVILYTE-N 420; 1.48; 5.72; 11.2 g/438.4g; g/438.4g; g/438.4g; g/438.4g Details
GAVILYTE-N 420; 1.48; 5.72; 11.2 g/438.4g; g/438.4g; g/438.4g; g/438.4g
GAVILYTE-N is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE.
MedlinePlus Drug Summary
Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon. The medication also contains electrolytes to prevent dehydration and other serious side effects that may be caused by fluid loss as the colon is emptied.
Related Packages: 43386-0050-19Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Polyethylene glycol-electrolyte solution (PEG-ES)
Product Information
| NDC | 43386-0050 |
|---|---|
| Product ID | 43386-050_4dc13bff-b31b-4c32-ae98-9c467824a93d |
| Associated GPIs | 46992004302120 |
| GCN Sequence Number | 059931 |
| GCN Sequence Number Description | sodium chloride/NaHCO3/KCl/peg SOLN RECON 420G ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 25865 |
| HICL Sequence Number | 033276 |
| HICL Sequence Number Description | SODIUM CHLORIDE/SODIUM BICARBONATE/POTASSIUM CHLORIDE/PEG |
| Brand/Generic | Generic |
| Proprietary Name | GAVILYTE-N |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 420; 1.48; 5.72; 11.2 |
| Active Ingredient Units | g/438.4g; g/438.4g; g/438.4g; g/438.4g |
| Substance Name | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090019 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 43386-0050-19 (43386005019)
| NDC Package Code | 43386-050-19 |
|---|---|
| Billing NDC | 43386005019 |
| Package | 438.4 g in 1 BOTTLE (43386-050-19) |
| Marketing Start Date | 2009-05-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.00927 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | GAVILYTE-N SOLUTION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |