Home NDC 68788-8552 Metronidazole
Product NDC 68788-8552
11-digit product format 687888552
Labeler code 68788
Product ID 68788-8552_1969dc9c-4ced-498b-90a6-c027846b7aaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA217128
Marketing category ANDA
Marketing start 2023-11-20
Substance METRONIDAZOLE
Active strength 7.5 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 68788-8552 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-8552 68788-8552-4 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A217128-001 METRONIDAZOLE METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217128-001 BX
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.
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 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2023-04-21 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217128-001 METRONIDAZOLE 0.75% CREAM / TOPICAL BX 2023-04-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 2027-12-31 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 311678 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 68788-8552-4 Metronidazole 1 in 1 CARTON CREAM 1 2 68788-8552-4 Metronidazole 45 g in 1 TUBE CREAM 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8552 METRONIDAZOLE CREAM [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 2 package rows 20250117_59e53582-244a-4e9d-b18e-75dddc6a5052.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 · 3 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 68788-8552-4 68788855204 1 TUBE in 1 CARTON (68788-8552-4) / 45 g in 1 TUBE 1 tube 2023-11-20 No No Current