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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX 2005-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX 2005-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX 2005-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX 2005-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021806-001 VANDAZOLE 0.75% GEL / VAGINAL BX RS 2005-05-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021806-001 7456207 2024-09-22 Drug product 2011-01-20 cb3db0bc1861…
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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