GaviLyte - C
- Product NDC
- 43386-060
- 11-digit product format
- 433860060
- Labeler code
- 43386
- Product ID
- 43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polyethylene glycol-3350 and electrolytes with Flavor Pack
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA090186
- Marketing category
- ANDA
- Marketing start
- 2009-01-06
- Substance
- POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
- Active strength
- 240; 2.98; 6.72; 5.84; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [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
- GaviLyte - C
- Brand name suffix
- TM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 240 g/278.26g |
| POTASSIUM CHLORIDE | 2.98 g/278.26g |
| SODIUM BICARBONATE | 6.72 g/278.26g |
| SODIUM CHLORIDE | 5.84 g/278.26g |
| SODIUM SULFATE ANHYDROUS | 22.72 g/278.26g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G2M7P15E5P, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X, 36KCS0R750 |
| Rxcui | 966914, 967023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-060-19 | GaviLyte - CTM | 278.26 g in 1 BOTTLE | POWDER, FOR SOLUTION | 278.26 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POLYETHYLENE GLYCOL 3350 | ACTIVE INGREDIENT | G2M7P15E5P | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM BICARBONATE | ACTIVE INGREDIENT | 8MDF5V39QO | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM SULFATE ANHYDROUS | ACTIVE INGREDIENT | 36KCS0R750 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CHLORIDE ION | ACTIVE MOIETY | Q32ZN48698 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POLYETHYLENE GLYCOL 3350 | ACTIVE MOIETY | G2M7P15E5P | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SULFATE ION | ACTIVE MOIETY | 7IS9N8KPMG | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| ALPHA-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-060 | GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20171228_a8b15625-ca7c-4d57-9f36-3ac2a6d13665.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 |
|---|
| 43386-060-19 | 43386006019 | 278.26 g in 1 BOTTLE (43386-060-19) | 278.26 g | 2009-06-01 | 0000-00-00 | Yes | No | Current |