miconazole nitrate

Generic: miconazole nitrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name miconazole nitrate
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2035
Product ID 51672-2035_362a2e22-e1bb-aae7-e063-6394a90a33f0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074444
Listing Expiration 2026-12-31
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 516722035
Hyphenated Format 51672-2035

Supplemental Identifiers

RxCUI
998540
UPC
0351672203566
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 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 (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATOR
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (2)

51672-2035-6 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATOR 51672-2035-7 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 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": "362a2e22-e1bb-aae7-e063-6394a90a33f0", "openfda": {"upc": ["0351672203566"], "unii": ["VW4H1CYW1K"], "rxcui": ["998540"], "spl_set_id": ["6b34d0be-4bcd-4dff-b732-7fbd46765019"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "51672-2035-6", "marketing_start_date": "19970113"}, {"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "51672-2035-7", "marketing_start_date": "19970113"}], "brand_name": "Miconazole Nitrate", "product_id": "51672-2035_362a2e22-e1bb-aae7-e063-6394a90a33f0", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-2035", "generic_name": "Miconazole Nitrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "20261231"}