miconazole 7

Generic: miconazole nitrate

Labeler: quality choice (chain drug marketing association)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole 7
Generic Name miconazole nitrate
Labeler quality choice (chain drug marketing association)
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)

Identifiers & Regulatory

Product NDC 63868-198
Product ID 63868-198_d353be3c-4a6d-4c33-b443-1a5fe60a7531
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074164
Listing Expiration 2026-12-31
Marketing Start 2010-07-01

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63868198
Hyphenated Format 63868-198

Supplemental Identifiers

RxCUI
998540
UPC
0635515999107
UNII
VW4H1CYW1K

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 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 (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

63868-198-45 1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 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": "d353be3c-4a6d-4c33-b443-1a5fe60a7531", "openfda": {"upc": ["0635515999107"], "unii": ["VW4H1CYW1K"], "rxcui": ["998540"], "spl_set_id": ["68667d2e-d4d0-46e7-9d84-0f23fdac1cf7"], "manufacturer_name": ["QUALITY CHOICE (Chain Drug Marketing Association)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "63868-198-45", "marketing_start_date": "20100701"}], "brand_name": "Miconazole 7", "product_id": "63868-198_d353be3c-4a6d-4c33-b443-1a5fe60a7531", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "63868-198", "generic_name": "Miconazole Nitrate", "labeler_name": "QUALITY CHOICE (Chain Drug Marketing Association)", "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": "20100701", "listing_expiration_date": "20261231"}