Home NDC 68083-373-04 Metronidazole
Product NDC 68083-373
Requested package NDC 68083-373-04
11-digit product format 680830373
Labeler code 68083
Product ID 68083-373_01c8a10a-cb89-4879-a9ff-e2ca4e033c99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA212435
Marketing category ANDA
Marketing start 2020-08-03
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 1 .
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 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212435-001 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 2026-02-19 14:30 UTC 2026-02 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212435-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP 2020-08-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
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 68083-373-01 Metronidazole 100 mL in 1 BAG INJECTION, SOLUTION 100 11 68083-373-01 Metronidazole 1 in 1 POUCH INJECTION, SOLUTION 1 11 68083-373-04 Metronidazole 4 in 1 CARTON INJECTION, SOLUTION 4 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-373 METRONIDAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 9 Current NDC, Legacy NDC, 3 package rows 20240731_74cf111a-9b83-4f93-b0e8-bc252d471d43.zip
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 68083-373-04 68083037304 4 POUCH in 1 CARTON (68083-373-04) / 1 BAG in 1 POUCH (68083-373-01) / 100 mL in 1 BAG 4 pouch 2020-08-03 0000-00-00 No No Current