NDC 43538-182

Rosadan

Metronidazole

Rosadan is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Metronidazole.

• Product ID: 43538-182_3b46f039-e92b-42dc-8e50-eb6ddc5700c0
• NDC: 43538-182
• Product Type: Human Prescription Drug
• Proprietary Name: Rosadan
• Generic Name: Metronidazole
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-04-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078178
• Labeler Name: Medimetriks Pharmaceuticals, Inc.
• Substance Name: METRONIDAZOLE
• Active Ingredient Strength: 8 mg/g
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43538-182-45

1 TUBE in 1 CARTON (43538-182-45) > 45 g in 1 TUBE

• Marketing Start Date: 2012-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43538-182-45 [43538018245]

Rosadan GEL

• Marketing Category: ANDA
• Application Number: ANDA078178
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-04-15

Drug Details

Active Ingredients

Ingredient	Strength
METRONIDAZOLE	7.5 mg/g

OpenFDA Data

• SPL SET ID: 99eaa138-0cfa-45e1-abbf-a88271707979
• Manufacturer:
  • Medimetriks Pharmaceuticals, Inc.
• UNII:
  • 140QMO216E
• RxNorm Concept Unique ID - RxCUI:
  • 1251688
  • 311679

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

Medicade Reported Pricing

43538018245 ROSADAN 0.75% GEL

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
43538-182	Rosadan	Rosadan
43538-180	Rosadan	Rosadan
43538-181	Rosadan	Rosadan
43538-183	Rosadan	Rosadan
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