Home NDC 46708-435 Metronidazole
Product NDC 46708-435
11-digit product format 467080435
Labeler code 46708
Product ID 46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA079065
Marketing category ANDA
Marketing start 2016-12-09
Substance METRONIDAZOLE
Active strength 375 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 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 A079065-001 METRONIDAZOLE METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079065-001 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 · 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 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 375 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 199055 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-435-30 Metronidazole 30 in 1 BOTTLE CAPSULE 30 3 46708-435-31 Metronidazole 100 in 1 BOTTLE CAPSULE 100 3 46708-435-50 Metronidazole 50 in 1 BOTTLE CAPSULE 50 3 46708-435-71 Metronidazole 500 in 1 BOTTLE CAPSULE 500 3 46708-435-91 Metronidazole 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-435 METRONIDAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 5 package rows 20230202_387053e5-7eda-4282-b58a-5789430a2e99.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 46708-435-30 46708043530 30 CAPSULE in 1 BOTTLE (46708-435-30) 30 capsule 2016-12-09 0000-00-00 No No Current 46708-435-31 46708043531 100 CAPSULE in 1 BOTTLE (46708-435-31) 100 capsule 2016-12-09 0000-00-00 No No Current 46708-435-50 46708043550 50 CAPSULE in 1 BOTTLE (46708-435-50) 50 capsule 2016-12-09 0000-00-00 No No Current 46708-435-71 46708043571 500 CAPSULE in 1 BOTTLE (46708-435-71) 500 capsule 2016-12-09 0000-00-00 No No Current 46708-435-91 46708043591 1000 CAPSULE in 1 BOTTLE (46708-435-91) 1000 capsule 2016-12-09 0000-00-00 No No Current