Home NDC 0264-5535 METRONIDAZOLE
Product NDC 0264-5535
11-digit product format 002645535
Labeler code 0264
Product ID 0264-5535_d16a1d82-f9ec-4c94-a9d6-0ccaba6dca82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METRONIDAZOLE
Dosage form SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA018900
Marketing category NDA
Marketing start 1983-09-29
Substance METRONIDAZOLE
Active strength 500 mg/100mL
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 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 N018900-001 METRO I.V. IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION RLD 1983-09-29
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 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION RLD 1983-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION RLD 1983-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018900-001 METRO I.V. IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-09-29 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base METRONIDAZOLE
Listing expiration 2027-12-31 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 0264-5535-32 METRONIDAZOLE 4 in 1 CARTON SOLUTION 4 30 0264-5535-32 METRONIDAZOLE 6 in 1 CASE SOLUTION 6 30
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-5535 METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] 28 Current NDC, Legacy NDC, 2 package rows 20250328_fd191c06-9d3b-4e46-9f79-90f6af614947.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 0264-5535-32 00264553532 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER 6 carton 1983-09-29 0000-00-00 No No Current