Home NDC 25021-131-82 Metronidazole
Product NDC 25021-131
Requested package NDC 25021-131-82
11-digit product format 250210131
Labeler code 25021
Product ID 25021-131_630e05cd-e000-4b75-8a65-fe2bbabee11d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA206191
Marketing category ANDA
Marketing start 2009-11-15
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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 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 25021-131-82 Metronidazole 1 in 1 POUCH INJECTION, SOLUTION 1 9 25021-131-82 Metronidazole 24 in 1 CARTON INJECTION, SOLUTION 24 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-131 METRONIDAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 2 package rows 20250212_d46870f5-e2b1-46bd-8413-4a0a8bcf3175.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 25021-131-82 25021013182 24 POUCH in 1 CARTON (25021-131-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 24 pouch 2009-11-15 0000-00-00 No No Current