NDC codes

FDA NDC Directory
Product NDC (as listed)65649-201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65649-0201Add 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
65649-201-7565649020175656490201751 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCHMarketed from Oct 1, 2006
65649-201-7665649020176656490201761 KIT in 1 CONTAINER (65649-201-76) * 1 L in 1 POUCH * 1 L in 1 POUCHMarketed from Oct 1, 2006

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)
MoviPrep
Generic name (nonproprietary)
polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate
Dosage form
Kit
Labeler
Salix Pharmaceuticals, Inc.NDC labeler code 65649
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021881
Marketing start
Listing expires
Identifiers
Product ID 65649-201_1e0ca4a8-3483-40c3-b75f-6ae9cea97652SPL ID 1e0ca4a8-3483-40c3-b75f-6ae9cea97652SPL set ID 8ff46193-2a3b-4de0-9572-775dda8cd8b2RxCUI 800915, 800918

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

N465649020175 followed by a unit qualifier and the quantity

Package 65649-0201-75. 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)

MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. MoviPrep is an osmotic laxative indicated for cleansing of the colon as a 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 65649-201

What is NDC 65649-201?
65649-201 is the product NDC for MoviPrep 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?
MoviPrep (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 MoviPrep?
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 NDA 021881

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

FDA NDC Directory listings under NDA 021881
ProductStrengthForm · routeLabelerProduct NDC
PEG-3350, Electrolytes, and Ascorbatepolyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid—KitOceanside Pharmaceuticals68682-201

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