GAVILAX
- Product NDC
- 17856-0312
- 11-digit product format
- 178560312
- Labeler code
- 17856
- Product ID
- 17856-0312_3a86670e-4e74-3a85-e063-6394a90ad435
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA091077
- Marketing category
- ANDA
- Marketing start
- 2021-01-26
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-0312-1 | GAVILAX | 17 g in 1 BAG | POWDER, FOR SOLUTION | 17 | | 14 |
| 17856-0312-2 | GAVILAX | 8.5 g in 1 BAG | POWDER, FOR SOLUTION | 8.5 | | 14 |
| 17856-0312-3 | GAVILAX | 17 g in 1 CUP | POWDER, FOR SOLUTION | 17 | | 14 |
| 17856-0312-4 | GAVILAX | 4 g in 1 BAG | POWDER, FOR SOLUTION | 4 | | 14 |
| 17856-0312-5 | GAVILAX | 8.5 g in 1 CUP | POWDER, FOR SOLUTION | 8.5 | | 14 |
| 17856-0312-5 | GAVILAX | 50 in 1 CASE | POWDER, FOR SOLUTION | 50 | | 14 |
| 17856-0312-6 | GAVILAX | 72 in 1 CASE | POWDER, FOR SOLUTION | 72 | | 14 |
| 17856-0312-6 | GAVILAX | 4.5 g in 1 POUCH | POWDER, FOR SOLUTION | 4.5 | | 14 |
| 17856-0312-7 | GAVILAX | 4.25 g in 1 BAG | POWDER, FOR SOLUTION | 4.25 | | 14 |
| 17856-0312-7 | GAVILAX | 50 in 1 BOX, UNIT-DOSE | POWDER, FOR SOLUTION | 50 | | 14 |
| 17856-0312-8 | GAVILAX | 72 in 1 BOX, UNIT-DOSE | POWDER, FOR SOLUTION | 72 | | 14 |
| 17856-0312-8 | GAVILAX | 4.25 g in 1 BAG | POWDER, FOR SOLUTION | 4.25 | | 14 |
| 17856-0312-9 | GAVILAX | 4.25 g in 1 CUP | POWDER, FOR SOLUTION | 4.25 | | 14 |
| 17856-0312-9 | GAVILAX | 50 in 1 BOX, UNIT-DOSE | POWDER, FOR SOLUTION | 50 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0312 | GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 11 | Current NDC, Legacy NDC, 14 package rows | 20250529_c9688f06-b6db-4afb-b8ff-ef5fb8bf9946.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 |
|---|
| 17856-0312-1 | 17856031201 | 17 g in 1 BAG (17856-0312-1) | 17 g | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-2 | 17856031202 | 8.5 g in 1 BAG (17856-0312-2) | 8.5 g | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-3 | 17856031203 | 17 g in 1 CUP (17856-0312-3) | 17 g | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-4 | 17856031204 | 4 g in 1 BAG (17856-0312-4) | 4 g | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-5 | 17856031205 | 50 CUP in 1 CASE (17856-0312-5) / 8.5 g in 1 CUP | 50 cup | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-6 | 17856031206 | 72 POUCH in 1 CASE (17856-0312-6) / 4.5 g in 1 POUCH | 72 pouch | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-0312-7 | 17856031207 | 50 BAG in 1 BOX, UNIT-DOSE (17856-0312-7) / 4.25 g in 1 BAG | 50 bag | 2023-10-10 | | No | No | Historical |
| 17856-0312-8 | 17856031208 | 72 BAG in 1 BOX, UNIT-DOSE (17856-0312-8) / 4.25 g in 1 BAG | 72 bag | 2025-07-22 | | No | No | Historical |
| 17856-0312-9 | 17856031209 | 50 CUP in 1 BOX, UNIT-DOSE (17856-0312-9) / 4.25 g in 1 CUP | 50 cup | 2025-07-22 | | No | No | Historical |