Polyethylene Glycol 3350, NF Powder for Solution, Laxative
- Product NDC
- 45861-083
- 11-digit product format
- 458610083
- Labeler code
- 45861
- Product ID
- 45861-083_2f83c954-31c2-fa95-e063-6394a90a5861
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350, NF Powder for Solution, Laxative
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Pharmaceutica North America, Inc.
- Application
- ANDA090812
- Marketing category
- ANDA
- Marketing start
- 2025-02-10
- Substance
- POLYETHYLENE GLYCOL 3350
- Active strength
- 17 g/d
- 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, NF Powder for Solution, Laxative
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/d |
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 |
|---|
| 45861-083-05 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 238 d in 1 BOTTLE | POWDER, FOR SOLUTION | 238 | | 2 |
| 45861-083-06 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 2 in 1 BOX | POWDER, FOR SOLUTION | 2 | | 2 |
| 45861-083-06 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 476 d in 1 BOTTLE | POWDER, FOR SOLUTION | 476 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45861-083 | POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [PHARMACEUTICA NORTH AMERICA, INC.] | 2 | Current NDC, 3 package rows | 20250306_d048111f-8144-4d51-a0c2-a967b2bce455.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45861-083-05 | 45861008305 | 238 d in 1 BOTTLE (45861-083-05) | 238 d | 2025-02-10 | No | No | Historical |
| 45861-083-06 | 45861008306 | 2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLE | 2 bottle | 2025-02-10 | No | No | Historical |