vandazole

Generic: metronidazole

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vandazole
Generic Name metronidazole
Labeler upsher-smith laboratories, llc
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Upsher-smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0860
Product ID 0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021806
Marketing Start 2005-10-04
Marketing End 2027-05-31

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450860
Hyphenated Format 0245-0860

Supplemental Identifiers

RxCUI
142046 608934
UNII
140QMO216E
NUI
N0000175435 M0014907

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 vandazole (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number NDA021806 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

0245-0860-70 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

Vandazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "44ff0133-9823-f57e-e063-6294a90a5c73", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046", "608934"], "spl_set_id": ["27d71471-8f89-4a1e-8c55-020a58961454"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Upsher-smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "0245-0860-70", "marketing_end_date": "20270531", "marketing_start_date": "20051004"}], "brand_name": "Vandazole", "product_id": "0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0245-0860", "generic_name": "Metronidazole", "labeler_name": "Upsher-smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vandazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "NDA021806", "marketing_category": "NDA", "marketing_end_date": "20270531", "marketing_start_date": "20051004"}