Home NDC 63187-511 Metronidazole
Product NDC 63187-511
11-digit product format 631870511
Labeler code 63187
Product ID 63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
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 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# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-511 METRONIDAZOLE TABLET [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 6 package rows 20221211_205054e1-8172-47dc-931c-a18a60e7e9f0.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 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 ndc (product): 63187-511
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 63187-511-14 63187051114 14 TABLET in 1 BOTTLE (63187-511-14) 14 tablet 2021-08-12 0000-00-00 No No Current 63187-511-21 63187051121 21 TABLET in 1 BOTTLE (63187-511-21) 21 tablet 2021-08-12 0000-00-00 No No Current 63187-511-28 63187051128 28 TABLET in 1 BOTTLE (63187-511-28) 28 tablet 2021-08-12 0000-00-00 No No Current 63187-511-30 63187051130 30 TABLET in 1 BOTTLE (63187-511-30) 30 tablet 2021-08-12 0000-00-00 No No Current 63187-511-60 63187051160 60 TABLET in 1 BOTTLE (63187-511-60) 60 tablet 2021-08-12 0000-00-00 No No Current 63187-511-90 63187051190 90 TABLET in 1 BOTTLE (63187-511-90) 90 tablet 2021-08-12 0000-00-00 No No Current