Prescription drug · ANDA
GaviLyte - C TM NDC 43386-060
polyethylene glycol-3350 and electrolytes with flavor pack · Polyethylene glycol 3350 240 g/278.26g + 4 more ingredients · Powder, For solution · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-060-19 | 43386006019 | 278.26 g in 1 BOTTLE (43386-060-19)Marketed from Jun 1, 2009 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- GaviLyte - C TMSuffix: TM
- Generic name (nonproprietary)
- polyethylene glycol-3350 and electrolytes with flavor pack
- Active ingredients
- Polyethylene glycol 3350 — 240 g/278.26gSodium chloride — 5.84 g/278.26gPotassium chloride — 2.98 g/278.26gSodium bicarbonate — 6.72 g/278.26gSodium sulfate anhydrous — 22.72 g/278.26g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090186
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8SPL ID 5105b61a-4ca7-4096-9cd0-cf22f46ffaf8SPL set ID a8b15625-ca7c-4d57-9f36-3ac2a6d13665RxCUI 966914, 967023UNII G2M7P15E5P, 451W47IQ8X, 660YQ98I10, 8MDF5V39QO, 36KCS0R750
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443386006019followed by a unit qualifier and the quantityPackage 43386-0060-19. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
Excerpt only. Read the full label for complete information.