GAVILAX
- Product NDC
- 68788-7508
- 11-digit product format
- 687887508
- Labeler code
- 68788
- Product ID
- 68788-7508_f868cc44-d891-42de-8c52-78e9d85651b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA091077
- Marketing category
- ANDA
- Marketing start
- 2009-10-09
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GAVILAX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G2M7P15E5P |
| Rxcui | 876193, 876214 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7508-2 | GAVILAX | 238 g in 1 BOTTLE | POWDER, FOR SOLUTION | 238 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7508 | GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240110_21654def-5ae0-422d-961b-1fe2456af00a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7508-2 | 68788750802 | 238 g in 1 BOTTLE (68788-7508-2) | 238 g | 2019-10-28 | 0000-00-00 | No | No | Current |