oravig

Generic: miconazole

Labeler: galt pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oravig
Generic Name miconazole
Labeler galt pharmaceuticals, llc
Dosage Form TABLET
Routes
BUCCAL
Active Ingredients

miconazole 50 mg/1

Manufacturer
Galt Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 61825-303
Product ID 61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022404
Listing Expiration 2027-12-31
Marketing Start 2021-12-31

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61825303
Hyphenated Format 61825-303

Supplemental Identifiers

RxCUI
998548 998550
UNII
7NNO0D7S5M
NUI
N0000175487 M0002083

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oravig (source: ndc)
Generic Name miconazole (source: ndc)
Application Number NDA022404 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (61825-303-14)
source: ndc

Packages (1)

61825-303-14 14 TABLET in 1 BOTTLE (61825-303-14)

Ingredients (1)

miconazole (50 mg/1)

Linked Drug Pages (1)

Oravig ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "47da8a7f-0d47-f1cd-e063-6394a90a84ad", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["7NNO0D7S5M"], "rxcui": ["998548", "998550"], "spl_set_id": ["dc2427ff-e566-4b48-b289-9e51c011250a"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Galt Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (61825-303-14)", "package_ndc": "61825-303-14", "marketing_start_date": "20211231"}], "brand_name": "Oravig", "product_id": "61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "61825-303", "generic_name": "Miconazole", "labeler_name": "Galt Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oravig", "active_ingredients": [{"name": "MICONAZOLE", "strength": "50 mg/1"}], "application_number": "NDA022404", "marketing_category": "NDA", "marketing_start_date": "20211231", "listing_expiration_date": "20271231"}