Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor
- Product NDC
- 64380-770
- 11-digit product format
- 643800770
- Labeler code
- 64380
- Product ID
- 64380-770_5ecacfb6-b0c7-4460-820c-9a4453dd16f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA204559
- Marketing category
- ANDA
- Marketing start
- 2015-04-14
- Substance
- POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
- Active strength
- 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L
- Pharmacologic classes
- Alkalinizing Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [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
- Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 3350 | 420 g/4L |
| POTASSIUM CHLORIDE | 1.48 g/4L |
| SODIUM BICARBONATE | 5.72 g/4L |
| SODIUM CHLORIDE | 11.2 g/4L |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8MDF5V39QO, 451W47IQ8X, 660YQ98I10, G2M7P15E5P |
| Rxcui | 801054 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-770-21 | Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor | 4 L in 1 JUG | POWDER, FOR SOLUTION | 4 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64380-770 | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED POWDER, FOR SOLUTION POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH LEMON FLAVOR POWDER, FOR SOLUTION POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH ORANGE FLAVOR POWDER, FOR SOLUTION [STRIDES PHARMA SCIENCE LIMITED] | 7 | Current NDC, Legacy NDC, 1 package rows | 20221110_37c111ec-5b62-42b9-bbb2-3b0c530e34c9.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 | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 7 |
| 801054 | polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution | SCD | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 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 | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 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 | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 7 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 7 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-770-21 | 64380077021 | 4 L in 1 JUG (64380-770-21) | 4 l | 2015-04-14 | 0000-00-00 | No | No | Current |