NDC 50458-675

VERMOX

Mebendazole

VERMOX is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Mebendazole.

• Product ID: 50458-675_086f72d0-a9b6-46ea-ac0d-53a4999fa3a2
• NDC: 50458-675
• Product Type: Human Prescription Drug
• Proprietary Name: VERMOX
• Generic Name: Mebendazole
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-20
• Marketing Category: NDA / NDA
• Application Number: NDA208398
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: MEBENDAZOLE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Anthelmintic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 50458-675-20

200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20)

• Marketing Start Date: 2016-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-675-20 [50458067520]

VERMOX TABLET, CHEWABLE

• Marketing Category: NDA
• Application Number: NDA208398
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-20

Drug Details

Active Ingredients

Ingredient	Strength
MEBENDAZOLE	500 mg/1

OpenFDA Data

• SPL SET ID: a720c424-517a-461b-8e13-6c37caf8aa3f
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 81G6I5V05I
• RxNorm Concept Unique ID - RxCUI:
  • 1855387
  • 1855385
• UPC Code:
  • 0350458675207

Pharmacological Class

• Antihelminthic [EPC]
• Anthelmintic [EPC]

NDC Crossover Matching brand name "VERMOX" or generic name "Mebendazole"

NDC	Brand Name	Generic Name
50458-675	VERMOX	mebendazole
50580-070	VERMOX	mebendazole
64896-669	Emverm	mebendazole