miconazole 7

Generic: miconazole nitrate

Labeler: h2-pharma, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole 7
Generic Name miconazole nitrate
Labeler h2-pharma, llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-730
Product ID 61269-730_99d7e457-231a-4766-b90a-ba6963b2525c
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 61269730
Hyphenated Format 61269-730

Supplemental Identifiers

RxCUI
998540
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 (61269-730-63) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

61269-730-63 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-63) / 45 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (2)

Miconazole 7 ndc-match (0.9) Miconazole 7 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "99d7e457-231a-4766-b90a-ba6963b2525c", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998540"], "spl_set_id": ["67dc7d38-a663-48d5-9abf-b3bd8dc0eddf"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-63)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "61269-730-63", "marketing_start_date": "20210315"}], "brand_name": "Miconazole 7", "product_id": "61269-730_99d7e457-231a-4766-b90a-ba6963b2525c", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "61269-730", "generic_name": "Miconazole Nitrate", "labeler_name": "H2-Pharma, LLC", "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"}