GAVILAX
- Product NDC
- 63187-368
- 11-digit product format
- 631870368
- Labeler code
- 63187
- Product ID
- 63187-368_f28b44fb-7018-43ee-9d1b-c8d6bdcb7894
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GAVILAX
- 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, 876214 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-368-23 | GAVILAX | 238 g in 1 BOTTLE | POWDER, FOR SOLUTION | 238 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-368 | GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 1 package rows | 20220602_199d6173-3fad-49e4-88fe-bde7223ed4c3.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 |
|---|
| 63187-368-23 | 63187036823 | 238 g in 1 BOTTLE (63187-368-23) | 238 g | 2016-09-01 | 0000-00-00 | No | No | Current |