NDC 64811-401

Solosec

Secnidazole

Solosec is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Ropack Inc.. The primary component is Secnidazole.

• Product ID: 64811-401_84b2ccb5-fe73-4b3d-e053-2a91aa0a3710
• NDC: 64811-401
• Product Type: Human Prescription Drug
• Proprietary Name: Solosec
• Generic Name: Secnidazole
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA209363
• Labeler Name: Ropack Inc.
• Substance Name: SECNIDAZOLE
• Active Ingredient Strength: 2 g/4.8g
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 64811-401-01

1 PACKET in 1 BOX, UNIT-DOSE (64811-401-01) > 2 g in 1 PACKET

• Marketing Start Date: 2018-03-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

Active Ingredients

Ingredient	Strength
SECNIDAZOLE	2 g/4.8g

OpenFDA Data

• SPL SET ID: b182b7f1-34ea-4c3f-8bf0-df35e83e73e2
• Manufacturer:
  • Ropack Inc.
• UNII:
  • R3459K699K
• RxNorm Concept Unique ID - RxCUI:
  • 1946692
  • 1946698

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

NDC Crossover Matching brand name "Solosec" or generic name "Secnidazole"

NDC	Brand Name	Generic Name
27437-051	SOLOSEC	secnidazole
64811-401	Solosec	SECNIDAZOLE