Home NDC 71335-0858 Metronidazole
Product NDC 71335-0858
11-digit product format 713350858
Labeler code 71335
Product ID 71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA070027
Marketing category ANDA
Marketing start 1990-09-30
Substance METRONIDAZOLE
Active strength 250 mg/1
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A070027-001 METRONIDAZOLE METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070027-001 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 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 250 mg/1
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 314106 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0858-0 2024-05-16 Metronidazole Tablets, USP 71335-0858-1 2024-05-16 Metronidazole Tablets, USP 71335-0858-2 2024-05-16 Metronidazole Tablets, USP 71335-0858-3 2024-05-16 Metronidazole Tablets, USP 71335-0858-4 2024-05-16 Metronidazole Tablets, USP 71335-0858-5 2024-05-16 Metronidazole Tablets, USP 71335-0858-6 2024-05-16 Metronidazole Tablets, USP 71335-0858-7 2024-05-16 Metronidazole Tablets, USP 71335-0858-8 2024-05-16 Metronidazole Tablets, USP 71335-0858-9 2024-05-16 Metronidazole Tablets, USP 71335-0858-0 2024-01-30 Metronidazole Tablets, USP 71335-0858-1 2024-01-30 Metronidazole Tablets, USP 71335-0858-2 2024-01-30 Metronidazole Tablets, USP 71335-0858-3 2024-01-30 Metronidazole Tablets, USP 71335-0858-4 2024-01-30 Metronidazole Tablets, USP 71335-0858-5 2024-01-30 Metronidazole Tablets, USP 71335-0858-6 2024-01-30 Metronidazole Tablets, USP 71335-0858-7 2024-01-30 Metronidazole Tablets, USP 71335-0858-8 2024-01-30 Metronidazole Tablets, USP 71335-0858-9 2024-01-30 Metronidazole Tablets, USP
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0858 METRONIDAZOLE TABLET [BRYANT RANCH PREPACK] 6 Current NDC, Legacy NDC, 10 package rows 20240823_ea635d05-b3c1-4f49-ace2-d091c20920da.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metronidazole METRONIDAZOLE REMEDYREPACK INC. ca450fad-0513-4c45-8ea0-1f46bcbf6a36 2026-03-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 Metronidazole METRONIDAZOLE Bryant Ranch Prepack ea635d05-b3c1-4f49-ace2-d091c20920da 2024-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 71335-0858 Metronidazole METRONIDAZOLE Teva Pharmaceuticals USA, Inc. 291a45f6-ed27-4dcc-8364-358d08623797 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 Metronidazole METRONIDAZOLE Proficient Rx LP 205054e1-8172-47dc-931c-a18a60e7e9f0 2022-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027
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 71335-0858-0 71335085800 7 TABLET in 1 BOTTLE (71335-0858-0) 7 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-1 71335085801 21 TABLET in 1 BOTTLE (71335-0858-1) 21 tablet 2019-05-13 0000-00-00 No No Current 71335-0858-2 71335085802 30 TABLET in 1 BOTTLE (71335-0858-2) 30 tablet 2019-12-26 0000-00-00 No No Current 71335-0858-3 71335085803 20 TABLET in 1 BOTTLE (71335-0858-3) 20 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-4 71335085804 60 TABLET in 1 BOTTLE (71335-0858-4) 60 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-5 71335085805 28 TABLET in 1 BOTTLE (71335-0858-5) 28 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-6 71335085806 14 TABLET in 1 BOTTLE (71335-0858-6) 14 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-7 71335085807 40 TABLET in 1 BOTTLE (71335-0858-7) 40 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-8 71335085808 42 TABLET in 1 BOTTLE (71335-0858-8) 42 tablet 2024-08-09 0000-00-00 No No Current 71335-0858-9 71335085809 56 TABLET in 1 BOTTLE (71335-0858-9) 56 tablet 2018-08-06 0000-00-00 No No Current