Home NDC 0404-9991 METRONIDAZOLE
Product NDC 0404-9991
11-digit product format 004049991
Labeler code 0404
Product ID 0404-9991_1f13748c-910c-4ec8-8669-ecf7507f8320
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA206191
Marketing category ANDA
Marketing start 2023-02-24
Substance METRONIDAZOLE
Active strength 500 mg/100mL
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 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206191-001 AP
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 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2019-02-25 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 500 mg/100mL
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 311683 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 0404-9991-00 METRONIDAZOLE 100 mL in 1 BAG INJECTION, SOLUTION 100 4 0404-9991-00 METRONIDAZOLE 1 in 1 BAG INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9991 METRONIDAZOLE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 3 Current NDC, 2 package rows 20240327_df7df946-c83f-4adf-9007-aff4f757a665.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 WG Critical Care, LLC e4ea0c09-cdd1-4708-962c-6ba28b989df3 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 Metronidazole METRONIDAZOLE Hospira, Inc. 49360d6f-c8b3-420e-af75-154cf7b05255 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 METRONIDAZOLE METRONIDAZOLE Henry Schein, Inc. df7df946-c83f-4adf-9007-aff4f757a665 2025-08-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 ndc (product): 0404-9991 Metronidazole METRONIDAZOLE Sagent Pharmaceuticals d46870f5-e2b1-46bd-8413-4a0a8bcf3175 2025-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0404-9991-00 00404999100 1 BAG in 1 BAG (0404-9991-00) / 100 mL in 1 BAG 1 bag 2023-02-24 No No Current