Home NDC 68682-202 Metronidazole
Product NDC 68682-202
11-digit product format 686820202
Labeler code 68682
Product ID 68682-202_0e74a7e8-92d3-4287-a130-b80624733587
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Oceanside Pharmaceuticals
Application NDA020743
Marketing category NDA
Marketing start 2023-08-01
Substance METRONIDAZOLE
Active strength 10 mg/60g
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 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 N020743-001 NORITATE METRONIDAZOLE 1% CREAM / TOPICAL RLD, RS 1997-09-26
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 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 10 mg/60g
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 311680 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 68682-202-60 Metronidazole 60 g in 1 TUBE CREAM 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-202 METRONIDAZOLE CREAM [OCEANSIDE PHARMACEUTICALS] 2 Current NDC, 1 package rows 20230801_cdf2e251-4bbc-4434-9b00-bef6284491e4.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 · 2 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 68682-202-60 68682020260 60 g in 1 TUBE (68682-202-60) 60 g 2023-08-01 No No Current