NDC codes

FDA NDC Directory
Product NDC (as listed)60635-118Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60635-0118Add 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
60635-118-01606350118011 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTERMarketed from Jun 22, 2016

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)
Varithena
Generic name (nonproprietary)
polidocanol
Dosage form
Kit
Labeler
Boston Scientific CorporationNDC labeler code 60635
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 205098
Marketing start
Listing expires
Identifiers
Product ID 60635-118_130d8efd-d543-4b07-b99b-a4c779085dd6SPL ID 130d8efd-d543-4b07-b99b-a4c779085dd6SPL set ID dfd6b4a0-b0dc-11e2-9e96-0800200c9a66RxCUI 1485068, 1485070

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

N460635011801 followed by a unit qualifier and the quantity

Package 60635-0118-01. 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)

VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. VARITHENA (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. ( 1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60635-118

What is NDC 60635-118?
60635-118 is the product NDC for Varithena (polidocanol) kit, listed with the FDA by Boston Scientific Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Varithena (Polidocanol).
Who is the labeler?
Boston Scientific Corporation, NDC labeler code 60635. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Varithena?
1 other product NDC are listed under this name. See all Varithena NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Varithena NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Varithenapolidocanol—KitBoston Scientific Corporation60635-13360635-0133-01

Other NDCs under NDA 205098

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

FDA NDC Directory listings under NDA 205098
ProductStrengthForm · routeLabelerProduct NDC
Varithenapolidocanol—KitBoston Scientific Corporation60635-133

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