Home NDC 71209-062 Metronidazole
Product NDC 71209-062
11-digit product format 712090062
Labeler code 71209
Product ID 71209-062_1b7de98f-0359-4ba0-8705-85bb7c53be03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA209794
Marketing category ANDA
Marketing start 2017-12-29
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209794-001 METRONIDAZOLE METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 A209794-002 METRONIDAZOLE METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209794-001 METRONIDAZOLE 250MG TABLET / ORAL AB 2017-12-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209794-002 METRONIDAZOLE 500MG TABLET / ORAL AB 2017-12-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311681 Internal RxNorm lookup 314106 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 71209-062-02 Metronidazole 50 in 1 BOTTLE TABLET, FILM COATED 50 11 71209-062-10 Metronidazole 500 in 1 BOTTLE TABLET, FILM COATED 500 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-062 METRONIDAZOLE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 2 package rows 20240424_0c55bfc1-770a-4cce-a5dd-446000b24f16.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 Bryant Ranch Prepack 5cf3cc1f-601e-4997-bfb2-a573c31c8189 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209794 application number: ANDA209794 Metronidazole METRONIDAZOLE Bryant Ranch Prepack 4748ba37-9d66-497d-aa9f-ca2d541c5f41 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209794 application number: ANDA209794 Metronidazole METRONIDAZOLE Kanchan Healthcare Inc 8836334e-6db4-44be-bc9e-099b26322cf4 2026-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209794 application number: ANDA209794 Metronidazole METRONIDAZOLE Cadila Pharmaceuticals Limited 0c55bfc1-770a-4cce-a5dd-446000b24f16 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209794 application number: ANDA209794 ndc (product): 71209-062
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71209-062-02 71209006202 50 TABLET, FILM COATED in 1 BOTTLE (71209-062-02) 2017-12-29 0000-00-00 No No Current 71209-062-05 71209006205 50 TABLET, FILM COATED in 1 BOTTLE (71209-062-05) 2017-12-29 0000-00-00 No No Current 71209-062-10 71209006210 500 TABLET, FILM COATED in 1 BOTTLE (71209-062-10) 2017-12-29 0000-00-00 No No Current