Prescription drug · NDA
Vermox (Mebendazole) NDC 50458-675
Mebendazole 500 mg/1 · Tablet, Chewable · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-675-20 | 50458067520 | 200 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
N450458067520followed by a unit qualifier and the quantityPackage 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.
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.