NDC 89141-250

ORAVIG

Miconazole

ORAVIG is a Buccal Tablet in the Human Prescription Drug category. It is labeled and distributed by Midatech Pharma Us, Inc.. The primary component is Miconazole.

• Product ID: 89141-250_129cc319-9c75-45c8-b39c-d86fa44398ef
• NDC: 89141-250
• Product Type: Human Prescription Drug
• Proprietary Name: ORAVIG
• Generic Name: Miconazole
• Dosage Form: Tablet
• Route of Administration: BUCCAL
• Marketing Start Date: 2010-04-16
• Marketing Category: NDA / NDA
• Application Number: NDA022404
• Labeler Name: Midatech Pharma US, Inc.
• Substance Name: MICONAZOLE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 89141-250-02

1 BOTTLE in 1 CARTON (89141-250-02) > 2 TABLET in 1 BOTTLE

• Marketing Start Date: 2015-10-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 89141-250-14 [89141025014]

ORAVIG TABLET

• Marketing Category: NDA
• Application Number: NDA022404
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-15

NDC 89141-250-02 [89141025002]

ORAVIG TABLET

• Marketing Category: NDA
• Application Number: NDA022404
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-15

Drug Details

Active Ingredients

Ingredient	Strength
MICONAZOLE	50 mg/1

OpenFDA Data

• SPL SET ID: a1bf6bf0-9197-4fc1-af9f-df7b9a1ad6ce
• Manufacturer:
  • Midatech Pharma US, Inc.
• UNII:
  • 7NNO0D7S5M
• RxNorm Concept Unique ID - RxCUI:
  • 998548
  • 998550
• UPC Code:
  • 0389141250148

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "ORAVIG" or generic name "Miconazole"

NDC	Brand Name	Generic Name
61825-303	Oravig	Miconazole
89141-250	ORAVIG	miconazole
67777-316	Dynarex Antifungal Powder	Miconazole
69020-208	MakeSense	Miconazole
61715-050	MICONAZOLE	MICONAZOLE
42669-073	Miconazole Foot Powder	Miconazole
15071-804	Rash Relief Antifungal	Miconazole