miconazole nitrate

Generic: miconazole nitrate

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name miconazole nitrate
Labeler a-s medication solutions
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4356
Product ID 50090-4356_e0ebd43f-a346-46cc-be47-7f4de5dff3e9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074444
Listing Expiration 2027-12-31
Marketing Start 1997-01-13

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904356
Hyphenated Format 50090-4356

Supplemental Identifiers

RxCUI
998540
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 nitrate (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA074444 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

50090-4356-0 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "e0ebd43f-a346-46cc-be47-7f4de5dff3e9", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998540"], "spl_set_id": ["a32fc37b-bcad-4f56-8dc6-cf36a6716196"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "50090-4356-0", "marketing_start_date": "20190614"}], "brand_name": "Miconazole Nitrate", "product_id": "50090-4356_e0ebd43f-a346-46cc-be47-7f4de5dff3e9", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50090-4356", "generic_name": "Miconazole Nitrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "ANDA074444", "marketing_category": "ANDA", "marketing_start_date": "19970113", "listing_expiration_date": "20271231"}