Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NDC 45802-868
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-868-01 | 4580208680145802086801 | 119 g in 1 BOTTLE (45802-868-01)Marketed from Nov 6, 2009 | |
| 45802-868-02 | 4580208680245802086802 | 238 g in 1 BOTTLE (45802-868-02)Marketed from Nov 4, 2009 | |
| 45802-868-03 | 4580208680345802086803 | 510 g in 1 BOTTLE (45802-868-03)Marketed from Nov 5, 2009 | |
| 45802-868-66 | 4580208686645802086866 | 14 PACKET in 1 CARTON (45802-868-66) / 17 g in 1 PACKETMarketed from Jul 16, 2018 |
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
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090685
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 45802-868_c7938c5a-5794-4952-ad6c-078a2b9a5243SPL ID c7938c5a-5794-4952-ad6c-078a2b9a5243
- Pharmacologic class
- Osmotic Laxative
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
N445802086801followed by a unit qualifier and the quantityPackage 45802-0868-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 45802-868
- What is NDC 45802-868?
- 45802-868 is the product NDC for Polyethylene Glycol 3350, Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polyethylene Glycol 3350.
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?
- 29 other product NDCs are listed under this name. See all Polyethylene Glycol 3350 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Polyethylene Glycol 3350 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurohealth LLC | 58602-910 | 58602-0910-0158602-0910-0258602-0910-03+4 more |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | L.N.K. International, Inc. | 50844-772 | 50844-0772-0150844-0772-0350844-0772-09+7 more |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | The Fresh Test, LLC | 87362-119 | 87362-0119-01 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurobindo Pharma Limited | 84386-125 | 84386-0125-0884386-0125-1484386-0125-24+1 more |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/1 | Powder, For solutionOral | YYBA Corp | 73581-913 | 73581-0913-40 |
| Polyethylene Glycol 3350instalax polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2104 | 51672-2104-0351672-2104-0551672-2104-09 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kesin Pharma Corporation | 81033-762 | 81033-0762-0181033-0762-1481033-0762-30 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | NorthStar Rx LLC | 72603-302 | 72603-0302-0272603-0302-0372603-0302-04 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | PIONEER LIFE SCIENCES, LLC | 72090-036 | 72090-0036-0172090-0036-0272090-0036-03 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0699 | 70000-0699-02 |
Other NDCs under ANDA 090685
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 |
|---|---|---|---|---|
| dg health clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Dolgencorp, LLC | 55910-306 |
| good neighbor pharmacy clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amerisource Bergen | 46122-805 |
| equaline clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | United Natural Foods, Inc. dba UNFI | 41163-306 |
| Members Mark clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Sam's West Inc | 68196-306 |
| berkley and jensen clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | BJWC | 68391-306 |
| clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Meijer Distribution Inc | 41250-306 |
| MiraLAX Orange Flavorpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bayer HealthCare LLC. | 11523-0122 |
| Good Neighbor Pharmacy ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amerisource Bergen | 46122-014 |
| Exchange Select ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Army & Air Force Exchange Service | 55301-306 |
| Good Sense Clear Laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Preferred Pharmaceuticals Inc. | 68788-8795 |
| kirkland signature laxaclear original prescription strengthpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Costco Wholesale Company | 63981-306 |
| purelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CVS Pharmacy | 59779-306 |
| gentle laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kroger Company | 30142-306 |
| Topcare ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Topco Associates LLC | 76162-119 |
| rugby PEG 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bryant Ranch Prepack | 72162-2155 |
| signature care clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Safeway | 21130-847 |
| purelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CVS Pharmacy | 69842-458 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bryant Ranch Prepack | 72162-2172 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-471 |
| Gentlelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kroger Company | 30142-504 |
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