Home NDC 70518-2400 Vandazole
Product NDC 70518-2400
11-digit product format 705182400
Labeler code 70518
Product ID 70518-2400_967bdce5-060b-2bde-e053-2995a90a99bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route VAGINAL
Labeler REMEDYREPACK INC.
Application NDA021806
Marketing category NDA
Marketing start 2019-11-01
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 8 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2400-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-2400-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-2400-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-2400-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-2400-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-2400-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-2400-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-2400-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-2400-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2400-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2400-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2400-0 557ba5c1ecfa…9c80585c8c6e…
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…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vandazole METRONIDAZOLE Upsher-smith Laboratories, LLC 27d71471-8f89-4a1e-8c55-020a58961454 2025-12-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 021806 application number: NDA021806