Prescription drug · ANDA
Polyethylene Glycol 3350 and electrolyteswith Orange Flavor NDC 64380-767
polyethylene glycol 3350 and electrolytes with orange flavor · Polyethylene glycol 3350 236 g/4L + 4 more ingredients · Powder, For solution · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-767-21 | 6438007672164380076721 | 4 L in 1 JUG (64380-767-21)Marketed from Jan 10, 2019 |
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)
- Polyethylene Glycol 3350 and electrolyteswith Orange Flavor
- Generic name (nonproprietary)
- polyethylene glycol 3350 and electrolytes with orange flavor
- Active ingredients
- Polyethylene glycol 3350 — 236 g/4LSodium sulfate anhydrous — 22.74 g/4LSodium bicarbonate — 6.74 g/4LSodium chloride — 5.86 g/4LPotassium chloride — 2.97 g/4L
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204558
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)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)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 64380-767_d0b5c5be-e56a-4c27-909e-188913075072SPL ID d0b5c5be-e56a-4c27-909e-188913075072SPL set ID 48c741a9-9039-4fdb-a875-86d4ea968282RxCUI 966920UNII 36KCS0R750, 8MDF5V39QO, 660YQ98I10, H35KS68EE7, G2M7P15E5P, 451W47IQ8XUPC 0364380765219, 0364380766216, 0364380767213
- 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
N464380076721followed by a unit qualifier and the quantityPackage 64380-0767-21. 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)
Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1) Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults
Excerpt only. Read the full label for complete information.
About NDC 64380-767
- What is NDC 64380-767?
- 64380-767 is the product NDC for Polyethylene Glycol 3350 and electrolyteswith Orange Flavor, Polyethylene glycol 3350 236 g/4L + 4 more ingredients powder, for solution, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polyethylene Glycol 3350 and electrolyteswith Orange Flavor (Polyethylene Glycol 3350 and electrolytes with Orange Flavor).
- What is the active ingredient?
- Polyethylene glycol 3350, Sodium sulfate anhydrous, Sodium bicarbonate, Sodium chloride, Potassium chloride.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Polyethylene Glycol 3350 and electrolyteswith Orange Flavor?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 204558
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Polyethylene Glycol 3350 and electrolytes - Unflavored | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | Strides Pharma Science Limited | 64380-765 |
| Polyethylene Glycol 3350 and electrolytes with Lemon Flavor | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | Strides Pharma Science Limited | 64380-766 |