Home NDC 0025-1942-34 Flagyl
Product NDC 0025-1942
Requested package NDC 0025-1942-34
11-digit product format 000251942
Labeler code 0025
Product ID 0025-1942_9293f516-faa1-4c8d-a2f6-151d2f508d59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CAPSULE
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA020334
Marketing category NDA
Marketing start 1995-05-03
Substance METRONIDAZOLE
Active strength 375 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020334-001 FLAGYL METRONIDAZOLE 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020334-001 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 · 43 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 2026-09-14 22:38:34 2026-08 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020334-001 FLAGYL 375MG CAPSULE / ORAL AB RLD, RS 1995-05-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Flagyl
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199055 Internal RxNorm lookup 687211 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 0025-1942-34 Flagyl 100 in 1 CARTON CAPSULE 100 25 0025-1942-34 Flagyl 1 in 1 BLISTER PACK CAPSULE 1 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-1942 FLAGYL (METRONIDAZOLE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 23 Current NDC, Legacy NDC, 2 package rows 20241228_a2883ca1-5a9a-4259-9d80-46ab67274384.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 · 1 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 0025-1942-34 00025194234 100 BLISTER PACK in 1 CARTON (0025-1942-34) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 1995-05-03 0000-00-00 No No Current