NDC codes

FDA NDC Directory
Product NDC (as listed)65649-400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65649-0400Add 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
65649-400-0165649040001656490400011 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCHMarketed from May 4, 2018
65649-400-0265649040002656490400021 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCHMarketed from May 4, 2018 · Sample package

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)
Plenvu
Generic name (nonproprietary)
polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate
Dosage form
Kit
Labeler
Salix Pharmaceuticals, IncNDC labeler code 65649
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209381
Marketing start
Marketing end
Identifiers
Product ID 65649-400_4919e150-c34f-4ad3-8137-42f8cf91b997SPL ID 4919e150-c34f-4ad3-8137-42f8cf91b997SPL set ID 79f930fa-5674-4f30-8ae8-9448d6243797RxCUI 2045233, 2045243, 2045244, 2045245

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465649040001 followed by a unit qualifier and the quantity

Package 65649-0400-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

PLENVU ® is indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65649-400

What is NDC 65649-400?
65649-400 is the product NDC for Plenvu kit, listed with the FDA by Salix Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Plenvu (Polyethylene glycol 3350, Sodium sulfate, Sodium chloride, Potassium chloride, Ascorbic acid, Sodium ascorbate).
Who is the labeler?
Salix Pharmaceuticals, Inc, NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Plenvu?
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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