NDC 50382-050

MICONAZOLE

Antifungal

MICONAZOLE is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Priva Te Limited. The primary component is Miconazole Nitrate.

• Product ID: 50382-050_3484819a-ee23-4388-bafa-c3ee839ddae8
• NDC: 50382-050
• Product Type: Human Otc Drug
• Proprietary Name: MICONAZOLE
• Generic Name: Antifungal
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-07-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part333C
• Labeler Name: Galentic Pharma (India) Priva Te Limited
• Substance Name: MICONAZOLE NITRATE
• Active Ingredient Strength: 20 mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 50382-050-01

72 BOX in 1 CASE (50382-050-01) > 1 TUBE in 1 BOX > 28.4 g in 1 TUBE

• Marketing Start Date: 2013-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50382-050-01 [50382005001]

MICONAZOLE CREAM

• Marketing Category: OTC monograph final
• Application Number: part333C
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-07-18
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
MICONAZOLE NITRATE	20 mg/g

OpenFDA Data

• SPL SET ID: 853f5d10-99c3-4fdc-87b9-0ee6826e84ad
• Manufacturer:
  • Galentic Pharma (India) Priva Te Limited
• UNII:
  • VW4H1CYW1K
• RxNorm Concept Unique ID - RxCUI:
  • 998483

NDC Crossover Matching brand name "MICONAZOLE" or generic name "Antifungal"

NDC	Brand Name	Generic Name
37808-928	Miconazole	miconazole nitrate
50382-050	MICONAZOLE	antifungal
61715-050	MICONAZOLE	MICONAZOLE
68016-291	Miconazole	Miconazole Nitrate
50382-004	Antifungal	Antifungal
68001-475	Antifungal Cream	antifungal
68001-478	Antifungal Cream	antifungal
68001-481	Antifungal Cream	antifungal
77338-165	Astonea Miconazole nitrate	Antifungal
61767-231	Blossom Pharmaceuticals Antifungal	antifungal
67777-231	Dynarex Antifungal	antifungal
67777-316	Dynarex Antifungal Powder	Miconazole
69492-014	KERACTIL	ANTIFUNGAL
69020-208	MakeSense	Miconazole
42669-073	Miconazole Foot Powder	Miconazole
55681-165	Miconazole nitrate	Antifungal
68599-1471	Miconazole Nitrate	Antifungal
61825-303	Oravig	Miconazole
89141-250	ORAVIG	miconazole
15071-804	Rash Relief Antifungal	Miconazole