NDC codes

FDA NDC Directory
Product NDC (as listed)50458-675Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50458-0675Add 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
50458-675-2050458067520200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20)Marketed from Oct 20, 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)
Vermox
Generic name (nonproprietary)
mebendazole
Active ingredients
Mebendazole — 500 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208398
Marketing start
Listing expires
Identifiers
Product ID 50458-675_5757cf97-389e-4199-8b53-d32a18e55800SPL ID 5757cf97-389e-4199-8b53-d32a18e55800SPL set ID a720c424-517a-461b-8e13-6c37caf8aa3fRxCUI 1855385, 1855387UNII 81G6I5V05IUPC 0350458675207
Pharmacologic class
Anthelmintic

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

N450458067520 followed by a unit qualifier and the quantity

Package 50458-0675-20. 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)

VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50458-675

What is NDC 50458-675?
50458-675 is the product NDC for Vermox (mebendazole), Mebendazole 500 mg/1 tablet, chewable, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Vermox (Mebendazole).
What is the active ingredient?
Mebendazole.
Who is the labeler?
Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vermox?
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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