Home NDC 66993-936 metronidazole
Product NDC 66993-936
11-digit product format 669930936
Labeler code 66993
Product ID 66993-936_49c12f6c-f89d-4bdf-8732-ee5ef491e2fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route TOPICAL
Labeler Prasco Laboratories
Application NDA021789
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2005-06-30
Marketing end 2026-06-30
Substance METRONIDAZOLE
Active strength 10 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021789-001 METROGEL METRONIDAZOLE 1% GEL / TOPICAL AB RLD, RS 2005-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021789-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 6881726 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 7348317 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 6881726 2022-02-21 U-743 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021789-001 7348317 2022-02-21 U-743 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 6881726 2022-02-21 U-743 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021789-001 7348317 2022-02-21 U-743 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 6881726 2022-02-21 U-743 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 7348317 2022-02-21 U-743 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 6881726 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021789-001 7348317 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 6881726 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021789-001 7348317 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 6881726 2022-02-21 U-743 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021789-001 7348317 2022-02-21 U-743 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 6881726 2022-02-21 U-743 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021789-001 7348317 2022-02-21 U-743 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 6881726 2022-02-21 U-743 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021789-001 7348317 2022-02-21 U-743 Drug product ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021789-001 6881726 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021789-001 7348317 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 6881726 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 7348317 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 6881726 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021789-001 7348317 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 6881726 2022-02-21 U-743 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021789-001 7348317 2022-02-21 U-743 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 6881726 2022-02-21 U-743 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 7348317 2022-02-21 U-743 Drug product cb3db0bc1861…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66993-936-58 metronidazole 55 g in 1 BOTTLE, PUMP GEL 55 4 66993-936-61 metronidazole 60 g in 1 TUBE GEL 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-936 METRONIDAZOLE GEL [PRASCO LABORATORIES] 4 Current NDC, Legacy NDC, 2 package rows 20250125_7c35a751-58ca-4186-91a0-7c11d49144c4.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 66993-936-58 66993093658 55 g in 1 BOTTLE, PUMP (66993-936-58) 55 g 2017-02-02 0000-00-00 No No Current 66993-936-61 66993093661 60 g in 1 TUBE (66993-936-61) 60 g 2017-02-02 2026-06-30 No No Current