Over-the-counter drug · ANDA
Polyethylene glycol 3350 NDC 55154-8090
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-8090-5 | 5515480900555154809005 | 5 POUCH in 1 BAG (55154-8090-5) / 17 g in 1 POUCHMarketed from Jun 30, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203928
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 55154-8090_54341b32-d471-4e7c-bce4-5dd5de8a37caSPL ID 54341b32-d471-4e7c-bce4-5dd5de8a37caSPL set ID 2f5c975f-0d35-4f68-a27c-28af9a898733RxCUI 876193UNII G2M7P15E5P
- 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
N455154809005followed by a unit qualifier and the quantityPackage 55154-8090-05. 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)
Use ▪ relieves occasional constipation (irregularity) ▪ generally produces a bowel movement in 1 to 3 days
Excerpt only. Read the full label for complete information.
About NDC 55154-8090
- What is NDC 55154-8090?
- 55154-8090 is the product NDC for Polyethylene glycol 3350, Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 203928
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 |
|---|---|---|---|---|
| ez2go Polyethylene Glycol 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionTopical | Valley Medical Products, LLC | 76470-050 |
| Mix-In Laxative Packetspolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Wal-Mart Stores Inc | 49035-906 |
| Polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Major Pharmaceuticals | 0904-6931 |
| Polyethylene Glycol 3350instalax polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2104 |
| Polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Cardinal Health 107, LLC | 55154-2328 |
| Polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Cardinal Health 107, LLC | 55154-8091 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Cardinal Health 107, LLC | 55154-8184 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Gericare Pharmaceuticals | 57896-490 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | American Health Packaging | 60687-431 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | PIONEER LIFE SCIENCES, LLC | 72090-036 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | GLENMARK THERAPEUTICS INC., USA | 72657-196 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kesin Pharma Corporation | 81033-762 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | The Fresh Test, LLC | 87362-119 |
| Polyethylene Glycol 3350 Powder for Solutionpolyethylene glycol, unspecified | Polyethylene glycol 3350 17 g/17g | Powder, For solutionTopical | VALLEY MEDICAL PRODUCTS, LLC | 76470-069 |