NDC 0642-7466

Nuvessa

Metronidazole

Nuvessa is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Exeltis Usa, Inc.. The primary component is Metronidazole.

• Product ID: 0642-7466_820634d1-b2f5-4fec-bc60-7319060e1e34
• NDC: 0642-7466
• Product Type: Human Prescription Drug
• Proprietary Name: Nuvessa
• Generic Name: Metronidazole
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-03-10
• Marketing Category: NDA / NDA
• Application Number: NDA205223
• Labeler Name: Exeltis USA, Inc.
• Substance Name: METRONIDAZOLE
• Active Ingredient Strength: 65 mg/5g
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0642-7466-05

1 APPLICATOR in 1 CARTON (0642-7466-05) > 5 g in 1 APPLICATOR

• Marketing Start Date: 2018-03-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0642-7466-05 [00642746605]

Nuvessa GEL

• Marketing Category: NDA
• Application Number: NDA205223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-03-10

NDC 0642-7466-06 [00642746606]

Nuvessa GEL

• Marketing Category: NDA
• Application Number: NDA205223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-10

Drug Details

Active Ingredients

Ingredient	Strength
METRONIDAZOLE	65 mg/5g

OpenFDA Data

• SPL SET ID: 3b6ff39d-f84b-43b3-9b07-c0521c6d7968
• Manufacturer:
  • Exeltis USA, Inc.
• UNII:
  • 140QMO216E
• RxNorm Concept Unique ID - RxCUI:
  • 1604336
  • 1608253

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]
• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

NDC Crossover Matching brand name "Nuvessa" or generic name "Metronidazole"

NDC	Brand Name	Generic Name
0642-7466	Nuvessa	Nuvessa
0025-1821	Flagyl	Metronidazole
0025-1831	Flagyl	Metronidazole
0025-1942	Flagyl	metronidazole
0299-3836	MetroCream	metronidazole
0299-3820	METROGEL	metronidazole
0299-3838	MetroLotion	metronidazole
0115-1474	Metronidazole	Metronidazole
0143-9772	Metronidazole	Metronidazole
0168-0275	Metronidazole	Metronidazole
0168-0323	Metronidazole	Metronidazole
0168-0383	Metronidazole	Metronidazole
0179-1482	Metronidazole	Metronidazole
0264-5535	METRONIDAZOLE	METRONIDAZOLE
0338-1055	Metronidazole	Metronidazole
0187-5202	Noritate	metronidazole
0245-0860	Vandazole	Metronidazole