Home NDC 0245-0860 Vandazole
Product NDC 0245-0860
11-digit product format 002450860
Labeler code 0245
Product ID 0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route VAGINAL
Labeler Upsher-smith Laboratories, LLC
Application NDA021806
Marketing category NDA
Marketing start 2005-10-04
Marketing end 2027-05-31
Substance METRONIDAZOLE
Active strength 7.5 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021806-001 VANDAZOLE METRONIDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021806-001 BX
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021806-001 BX 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Vandazole Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 7.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 140QMO216E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 142046 Internal RxNorm lookup 608934 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0245-0860-70 Vandazole 70 g in 1 TUBE, WITH APPLICATOR GEL 70 14 0245-0860-70 Vandazole 1 in 1 CARTON GEL 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 METRONIDAZOLE ACTIVE MOIETY 140QMO216E VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0860 VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20241121_27d71471-8f89-4a1e-8c55-020a58961454.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0245-0860-70 00245086070 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR 2005-10-04 2027-05-31 No No Current