Polyethylene Glycol 3350
- Product NDC
- 51672-2104
- 11-digit product format
- 516722104
- Labeler code
- 51672
- Product ID
- 51672-2104_43e02980-58b9-7991-e063-6294a90a7a29
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- InstaLax Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA203928
- Marketing category
- ANDA
- Marketing start
- 2025-10-09
- Substance
- POLYETHYLENE GLYCOL 3350
- Active strength
- 17 g/17g
- Pharmacologic classes
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G2M7P15E5P |
| Rxcui | 876193 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-2104-3 | Polyethylene Glycol 3350 | 765 g in 1 CAN | POWDER, FOR SOLUTION | 765 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-2104-3 | 51672210403 | 765 g in 1 CAN (51672-2104-3) | 765 g | 2025-10-09 | No | No | Current |