miconazole 7

Generic: miconazole nitrate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole 7
Generic Name miconazole nitrate
Labeler nucare pharmaceuticals,inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3544
Product ID 68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074164
Listing Expiration 2026-12-31
Marketing Start 2021-03-15

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713544
Hyphenated Format 68071-3544

Supplemental Identifiers

RxCUI
998540
UPC
0368071354478
UNII
VW4H1CYW1K

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 miconazole 7 (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA074164 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

68071-3544-7 1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7) / 45 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Miconazole 7 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "2d3fbb35-987f-7d36-e063-6394a90a1acd", "openfda": {"upc": ["0368071354478"], "unii": ["VW4H1CYW1K"], "rxcui": ["998540"], "spl_set_id": ["0c055a0d-1031-e7d5-e063-6294a90a17e2"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "68071-3544-7", "marketing_start_date": "20231208"}], "brand_name": "Miconazole 7", "product_id": "68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68071-3544", "generic_name": "Miconazole Nitrate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole 7", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "ANDA074164", "marketing_category": "ANDA", "marketing_start_date": "20210315", "listing_expiration_date": "20261231"}