Home NDC 0187-5202 Noritate
Product NDC 0187-5202
11-digit product format 001875202
Labeler code 0187
Product ID 0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA020743
Marketing category NDA
Marketing start 2013-08-09
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 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 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 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 · 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 N020743-001 NORITATE 1% CREAM / TOPICAL RLD, RS 1997-09-26 caaa826d4ba7…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…
Additional Listing Data#
Finished product Yes
Brand name base Noritate
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213120 Internal RxNorm lookup 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 0187-5202-35 Noritate 3.5 g in 1 TUBE CREAM 3.5 13 0187-5202-60 Noritate 1 in 1 CARTON CREAM 1 13 0187-5202-60 Noritate 60 g in 1 TUBE CREAM 60 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5202 NORITATE (METRONIDAZOLE) CREAM [BAUSCH HEALTH US, LLC] 13 Current NDC, Legacy NDC, 3 package rows 20230426_706b09da-6cf9-421d-8e91-f3999474d322.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 Marketing end Sample Exclude flag Status 0187-5202-35 00187520235 3.5 g in 1 TUBE 3.5 g Historical 0187-5202-60 00187520260 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE 1 tube 2013-09-08 0000-00-00 No No Current