NDC 0299-3820

METROGEL

Metronidazole

METROGEL is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Metronidazole.

• Product ID: 0299-3820_23a9f282-a677-4fe8-8bda-9ec566d2918a
• NDC: 0299-3820
• Product Type: Human Prescription Drug
• Proprietary Name: METROGEL
• Generic Name: Metronidazole
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2005-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA021789
• Labeler Name: Galderma Laboratories, L.P.
• Substance Name: METRONIDAZOLE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0299-3820-00

3 g in 1 BLISTER PACK (0299-3820-00)

• Marketing Start Date: 2005-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0299-3820-00 [00299382000]

METROGEL GEL

• Marketing Category: NDA
• Application Number: NDA021789
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-06-30

NDC 0299-3820-01 [00299382001]

METROGEL GEL

• Marketing Category: NDA
• Application Number: NDA021789
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-10-19

NDC 0299-3820-03 [00299382003]

METROGEL GEL

• Marketing Category: NDA
• Application Number: NDA021789
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-06-30

NDC 0299-3820-60 [00299382060]

METROGEL GEL

• Marketing Category: NDA
• Application Number: NDA021789
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-08-29

NDC 0299-3820-99 [00299382099]

METROGEL GEL

• Marketing Category: NDA
• Application Number: NDA021789
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-19

Drug Details

Active Ingredients

Ingredient	Strength
METRONIDAZOLE	10 mg/g

OpenFDA Data

• SPL SET ID: ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • 140QMO216E
• RxNorm Concept Unique ID - RxCUI:
  • 577237
  • 605730
• UPC Code:
  • 0302993820017

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

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

NDC	Brand Name	Generic Name
0299-3820	METROGEL	metronidazole
0025-1821	Flagyl	Metronidazole
0025-1831	Flagyl	Metronidazole
0025-1942	Flagyl	metronidazole
0299-3836	MetroCream	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