NDC codes

FDA NDC Directory
Product NDC (as listed)68001-505Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0505Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68001-505-556800105055568001050555238 g in 1 BOTTLE (68001-505-55)Marketed from Jun 18, 2021
68001-505-696800105056968001050569510 g in 1 BOTTLE (68001-505-69)Marketed from Jun 18, 2021

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
Generic name (nonproprietary)
polyethylene glycol
Active ingredients
Polyethylene glycol 3350 — 17 g/17g
Dosage form
Powder, For suspension
Route
Oral
Labeler
BluePoint LaboratoriesNDC labeler code 68001
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091077
Marketing start
Listing expires
Other FDA classes
Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 68001-505_cc6e2865-14e2-1ac7-e053-2a95a90acbc0SPL ID cc6e2865-14e2-1ac7-e053-2a95a90acbc0SPL set ID c4cae70c-68da-0bbc-e053-2a95a90a395aUNII 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

N468001050555 followed by a unit qualifier and the quantity

Package 68001-0505-55. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68001-505

What is NDC 68001-505?
68001-505 is the product NDC for Polyethylene Glycol, Polyethylene glycol 3350 17 g/17g powder, for suspension, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Polyethylene Glycol.
What is the active ingredient?
Polyethylene glycol 3350.
Who is the labeler?
BluePoint Laboratories, NDC labeler code 68001. 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?
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 091077

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091077
ProductStrengthForm · routeLabelerProduct NDC
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAtlantic Biologicals Corp.17856-0310
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralATLANTIC BIOLOGICALS CORP.17856-0312
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralLupin Pharmaceuticals,Inc.43386-312
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralA-S Medication Solutions50090-5310
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralProficient Rx LP63187-368
Gavilaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralPreferred Pharmaceuticals, Inc.68788-7508

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