TRILYTE
- Product NDC
- 84386-013
- 11-digit product format
- 843860013
- Labeler code
- 84386
- Product ID
- 84386-013_79f5e596-8d51-4227-afcc-f5e341150957
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA076491
- Marketing category
- ANDA
- Marketing start
- 2026-04-14
- 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
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRILYTE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| 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 table| Field | Values |
|---|
| Unii | G2M7P15E5P, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X |
| Rxcui | 801054, 904158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-013-04 | TRILYTE | 4 L in 1 BOTTLE | POWDER, FOR SOLUTION | 4 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-013-04 | 84386001304 | 4 L in 1 BOTTLE (84386-013-04) | 4 l | 2026-04-14 | No | No | Historical |