Home NDC 0642-7466 Nuvessa
Product NDC 0642-7466
11-digit product format 006427466
Labeler code 0642
Product ID 0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route TOPICAL
Labeler Exeltis USA, Inc.
Application NDA205223
Marketing category NDA
Marketing start 2018-03-10
Substance METRONIDAZOLE
Active strength 65 mg/5g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 N205223-001 NUVESSA METRONIDAZOLE 1.3% GEL / VAGINAL RLD, RS 2014-03-24
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205223-001 8877792 2028-02-02 Drug product 2015-04-29 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 N205223-001 9198858 2032-06-28 U-1664 2015-12-15
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 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL AB RLD, RS 2014-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205223-001 NUVESSA 1.3% GEL / VAGINAL RLD, RS 2014-03-24 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 290 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 8946276 2032-06-28 U-1664 2015-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205223-001 9198858 2032-06-28 U-1664 2015-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 8877792 2028-02-02 Drug product 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 7893097 2028-02-19 Drug product 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 8658678 2028-06-27 U-1682 2015-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 10238634 2032-06-28 Drug product 2019-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205223-001 10596155 2032-06-28 Drug product 2020-04-07 b8a1b40f171c…
Additional Listing Data#
Finished product Yes
Brand name base Nuvessa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 65 mg/5g
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 1604336 Internal RxNorm lookup 1608253 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0642-7466 NUVESSA (METRONIDAZOLE) GEL [EXELTIS USA, INC.] 9 Current NDC, Legacy NDC, 4 package rows 20231111_3b6ff39d-f84b-43b3-9b07-c0521c6d7968.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 Units Marketing start Marketing end Sample Exclude flag Status 0642-7466-05 00642746605 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR 1 applicator 2018-03-10 0000-00-00 No No Current 0642-7466-06 00642746606 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR 1 applicator 2018-03-10 0000-00-00 Yes No Current