PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
- Product NDC
- 10572-302
- 11-digit product format
- 105720302
- Labeler code
- 10572
- Product ID
- 10572-302_d21af010-592c-bd05-e053-2995a90a3d39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Affordable Pharmaceuticals, LLC
- Application
- NDA019797
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-02-08
- 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
- Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [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 Activity [MoA], Osmotic Laxative [EPC], 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
- PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
- Listing expiration
- 2026-12-31
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 | G2M7P15E5P, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X |
| Rxcui | 801054 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10572-302-01 | PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride | 4 L in 1 BOTTLE | POWDER, FOR SOLUTION | 4 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10572-302-01 | ML - Milliliter | 10572-302 | 03c3ac3b-8a80-4dbe-bcd7-741c7d8c30b9 | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10572-302 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20211202_89ca6d56-527a-4be2-baea-531156f0a7be.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 | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
| 801054 | polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution | SCD | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
| 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 | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
| 801054 | PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution | SY | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
| 801054 | POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution | SY | 89ca6d56-527a-4be2-baea-531156f0a7be | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10572-302-01 | 10572030201 | 4 L in 1 BOTTLE (10572-302-01) | 4 l | 2013-03-01 | 0000-00-00 | No | No | Current |