Home NDC 68308-712 metronidazole
Product NDC 68308-712
11-digit product format 683080712
Labeler code 68308
Product ID 68308-712_0860a994-4d9d-4cac-a08c-fecb2ecbbacb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form LOTION
Route TOPICAL
Labeler Mayne Pharma Inc.
Application NDA020901
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-02-10
Substance METRONIDAZOLE
Active strength 7.5 mg/g
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 43 .
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 N020901-001 METROLOTION METRONIDAZOLE 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020901-001 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 · 43 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 2026-09-14 22:38:34 2026-08 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base metronidazole
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242736 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 68308-712-59 metronidazole 59.7 g in 1 BOTTLE LOTION 59.7 1 68308-712-59 metronidazole 1 in 1 CARTON LOTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-712 METRONIDAZOLE LOTION [MAYNE PHARMA INC.] 1 Current NDC, 2 package rows 20250211_5099691f-f216-4ac1-b057-99a845cc770f.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 Sample Exclude flag Status 68308-712-59 68308071259 1 BOTTLE in 1 CARTON (68308-712-59) / 59.7 g in 1 BOTTLE 1 bottle 2025-02-10 No No Current