Home NDC 63629-1386 Metronidazole
Product NDC 63629-1386
11-digit product format 636291386
Labeler code 63629
Product ID 63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA070033
Marketing category ANDA
Marketing start 1990-09-30
Substance METRONIDAZOLE
Active strength 500 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 A070033-001 METRONIDAZOLE METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070033-001 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 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070033-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1984-12-06 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 500 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 311681 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 63629-1386-0 2020-02-25 Metronidazole Tablets, USP 63629-1386-1 2020-02-25 Metronidazole Tablets, USP 63629-1386-2 2020-02-25 Metronidazole Tablets, USP 63629-1386-3 2020-02-25 Metronidazole Tablets, USP 63629-1386-4 2020-02-25 Metronidazole Tablets, USP 63629-1386-5 2020-02-25 Metronidazole Tablets, USP 63629-1386-6 2020-02-25 Metronidazole Tablets, USP 63629-1386-7 2020-02-25 Metronidazole Tablets, USP 63629-1386-8 2020-02-25 Metronidazole Tablets, USP 63629-1386-9 2020-02-25 Metronidazole Tablets, USP 63629-1386-0 2020-01-31 Metronidazole Tablets, USP 63629-1386-1 2020-01-31 Metronidazole Tablets, USP 63629-1386-2 2020-01-31 Metronidazole Tablets, USP 63629-1386-3 2020-01-31 Metronidazole Tablets, USP 63629-1386-4 2020-01-31 Metronidazole Tablets, USP 63629-1386-5 2020-01-31 Metronidazole Tablets, USP 63629-1386-6 2020-01-31 Metronidazole Tablets, USP 63629-1386-7 2020-01-31 Metronidazole Tablets, USP 63629-1386-8 2020-01-31 Metronidazole Tablets, USP 63629-1386-9 2020-01-31 Metronidazole Tablets, USP
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-1386 METRONIDAZOLE TABLET [BRYANT RANCH PREPACK] 29 Current NDC, Legacy NDC, 10 package rows 20241105_e1e7e127-e99e-80e9-1606-71261658b0c1.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metronidazole METRONIDAZOLE REMEDYREPACK INC. 53918705-d2fe-4c6b-9501-a619a8ad3991 2026-07-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033 Metronidazole METRONIDAZOLE REMEDYREPACK INC. 1a28dce0-07af-401a-a6ac-1c2ee559c668 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033 Metronidazole METRONIDAZOLE Redpharm Drug, inc. f426cddc-8b70-c0a7-e053-2995a90a74e0 2025-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033 Metronidazole METRONIDAZOLE Bryant Ranch Prepack e1e7e127-e99e-80e9-1606-71261658b0c1 2024-11-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 63629-1386 Metronidazole METRONIDAZOLE Proficient Rx LP e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205 2024-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033 Metronidazole METRONIDAZOLE Teva Pharmaceuticals USA, Inc. 291a45f6-ed27-4dcc-8364-358d08623797 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070033 application number: ANDA070033
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 63629-1386-0 63629138600 40 TABLET in 1 BOTTLE (63629-1386-0) 40 tablet 2010-08-03 0000-00-00 No No Current 63629-1386-1 63629138601 20 TABLET in 1 BOTTLE (63629-1386-1) 20 tablet 2004-12-16 0000-00-00 No No Current 63629-1386-2 63629138602 30 TABLET in 1 BOTTLE (63629-1386-2) 30 tablet 2004-12-20 0000-00-00 No No Current 63629-1386-3 63629138603 14 TABLET in 1 BOTTLE (63629-1386-3) 14 tablet 2007-03-26 0000-00-00 No No Current 63629-1386-4 63629138604 56 TABLET in 1 BOTTLE (63629-1386-4) 56 tablet 2006-08-10 0000-00-00 No No Current 63629-1386-5 63629138605 21 TABLET in 1 BOTTLE (63629-1386-5) 21 tablet 2009-02-12 0000-00-00 No No Current 63629-1386-6 63629138606 4 TABLET in 1 BOTTLE (63629-1386-6) 4 tablet 2008-06-12 0000-00-00 No No Current 63629-1386-7 63629138607 28 TABLET in 1 BOTTLE (63629-1386-7) 28 tablet 2008-07-07 0000-00-00 No No Current 63629-1386-8 63629138608 100 TABLET in 1 BOTTLE (63629-1386-8) 100 tablet 2010-08-26 0000-00-00 No No Current 63629-1386-9 63629138609 60 TABLET in 1 BOTTLE (63629-1386-9) 60 tablet 2022-03-08 0000-00-00 No No Current