NDC codes

FDA NDC Directory
Product NDC (as listed)11534-180Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11534-0180Add 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
11534-180-191153401801911534018019119 g in 1 BOTTLE (11534-180-19)Marketed from Jun 13, 2017
11534-180-281153401802811534018028238 g in 1 BOTTLE (11534-180-28)Marketed from Jun 13, 2017
11534-180-501153401805011534018050510 g in 1 BOTTLE (11534-180-50)Marketed from Jun 13, 2017

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 NF
Generic name (nonproprietary)
polyethylene glycol 3350
Active ingredients
Polyethylene glycol 3350 — 17 g/17g
Dosage form
Powder, For solution
Route
Oral
Labeler
SUNRISE PHARMACEUTICAL, INCNDC labeler code 11534
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206105
Marketing start
Listing expires
Other FDA classes
Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2SPL ID 020b7f87-0f3a-4223-a402-dea12a6c53d2SPL set ID ce5197a1-2677-4ffb-aef2-9221b28ebd23RxCUI 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

N411534018019 followed by a unit qualifier and the quantity

Package 11534-0180-19. 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 11534-180

What is NDC 11534-180?
11534-180 is the product NDC for Polyethylene Glycol 3350 NF (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by SUNRISE PHARMACEUTICAL, INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Polyethylene Glycol 3350 NF (Polyethylene glycol 3350).
What is the active ingredient?
Polyethylene glycol 3350.
Who is the labeler?
SUNRISE PHARMACEUTICAL, INC, NDC labeler code 11534. 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 NF?
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.

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