Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NDC 70000-0699
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · CARDINAL HEALTH 110, LLC. DBA LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0699-2 | 7000006990270000069902 | 10 PACKET in 1 CARTON (70000-0699-2) / 17 g in 1 PACKET (70000-0699-1)Marketed from Nov 8, 2024 |
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 110, LLC. DBA LEADERNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209017
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 70000-0699_048ca2e6-2e71-49f6-81b5-0e34a8f36b77SPL ID 048ca2e6-2e71-49f6-81b5-0e34a8f36b77SPL set ID 04cc4f2e-1725-4710-8cfb-73a6bdf52e4fRxCUI 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
N470000069902followed by a unit qualifier and the quantityPackage 70000-0699-02. 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 70000-0699
- What is NDC 70000-0699?
- 70000-0699 is the product NDC for Polyethylene Glycol 3350, Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER. 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 110, LLC. DBA LEADER, NDC labeler code 70000. 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 | GLENMARK THERAPEUTICS INC., USA | 72657-196 | 72657-0196-16 |
Other NDCs under ANDA 209017
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 |
|---|---|---|---|---|
| 365 WHOLE FOODS MARKET Polyethylene Glycol 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Whole Foods Market, Inc. | 42681-0059 |
| Comfortlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Family Dollar Stores, LLC | 55319-056 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurohealth LLC | 58602-805 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurohealth LLC | 58602-910 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurobindo Pharma Limited | 84386-125 |