Home NDC 80830-2465-9 Metronidazole
Product NDC 80830-2465
Requested package NDC 80830-2465-9
11-digit product format 808302465
Labeler code 80830
Product ID 80830-2465_ef0abec7-d5c4-4de2-8474-f16006304101
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA217665
Marketing category ANDA
Marketing start 2023-06-17
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 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 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217665-001 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.
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 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217665-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2023-05-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 80830-2465-1 Metronidazole 100 mL in 1 BAG INJECTION, SOLUTION 100 11 80830-2465-1 Metronidazole 1 in 1 POUCH INJECTION, SOLUTION 1 11 80830-2465-9 Metronidazole 24 in 1 CARTON INJECTION, SOLUTION 24 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80830-2465 METRONIDAZOLE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] 9 Current NDC, 3 package rows 20241017_843447a5-525c-48ea-860a-230db549fecb.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 Sample Exclude flag Status 80830-2465-9 80830246509 24 POUCH in 1 CARTON (80830-2465-9) / 1 BAG in 1 POUCH (80830-2465-1) / 100 mL in 1 BAG 24 pouch 2023-06-17 No No Current