GAVILYTE-N
- Product NDC
- 43386-050
- 11-digit product format
- 433860050
- Labeler code
- 43386
- Product ID
- 43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA090019
- Marketing category
- ANDA
- Marketing start
- 2009-05-28
- Substance
- POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
- Active strength
- 420; 1.48; 5.72; 11.2 g/438.4g; g/438.4g; g/438.4g; g/438.4g
- Pharmacologic classes
- 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], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GAVILYTE-N
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 3350 | 420 g/438.4g |
| POTASSIUM CHLORIDE | 1.48 g/438.4g |
| SODIUM BICARBONATE | 5.72 g/438.4g |
| SODIUM CHLORIDE | 11.2 g/438.4g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G2M7P15E5P, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X |
| Rxcui | 801054, 979099 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43386-050-19 | GAVILYTE-N | 438.4 g in 1 BOTTLE | POWDER, FOR SOLUTION | 438.4 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43386-050-19 | ML - Milliliter | 43386-050 | 5ea5079d-3aff-460b-bc2b-ad9deca80c88 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43386-050 | GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240110_27195187-75a3-431f-90d9-84da1b94e849.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979099 | Gavilyte-N Powder for Oral Solution | PSN | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 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 | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 979099 | polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution [GaviLyte-N] | SBD | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 801054 | polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution | SCD | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 979099 | Gavilyte-N (PEG-3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM) Powder for 4 L Oral Solution | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 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 | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 801054 | PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 979099 | POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution [GaviLyte-N] | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
| 979099 | POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution [GaviLyte-N] | SY | 27195187-75a3-431f-90d9-84da1b94e849 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43386-050-19 | 43386005019 | 438.4 g in 1 BOTTLE (43386-050-19) | 438.4 g | 2009-05-28 | 0000-00-00 | Yes | No | Current |