miconazole

Generic: miconazole nitrate

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole
Generic Name miconazole nitrate
Labeler h e b
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 40 mg/g

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-928
Product ID 37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091366
Listing Expiration 2026-12-31
Marketing Start 2020-03-17

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808928
Hyphenated Format 37808-928

Supplemental Identifiers

RxCUI
998544 2288429
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 (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA091366 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBE
source: ndc

Packages (1)

37808-928-14 1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBE

Ingredients (1)

miconazole nitrate (40 mg/g)

Linked Drug Pages (1)

Miconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "6b7d09f4-b857-4e61-9541-2a143bd5a8ee", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998544", "2288429"], "spl_set_id": ["83305fd6-2154-4b1b-aaec-3e2e56708fdb"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (37808-928-14)  / 5 g in 1 TUBE", "package_ndc": "37808-928-14", "marketing_start_date": "20200317"}], "brand_name": "Miconazole", "product_id": "37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "37808-928", "generic_name": "miconazole nitrate", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "40 mg/g"}], "application_number": "ANDA091366", "marketing_category": "ANDA", "marketing_start_date": "20200317", "listing_expiration_date": "20261231"}