Home NDC 67457-323 MOXIFLOXACIN HYDROCHLORIDE
Product NDC 67457-323
11-digit product format 674570323
Labeler code 67457
Product ID 67457-323_4719ed2a-9c0b-466a-90ee-a5f9f305cd02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MOXIFLOXACIN HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA205833
Marketing category ANDA
Marketing start 2017-10-03
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 400 mg/250mL
Pharmacologic classes Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05
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 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205833-001 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 400MG/250ML (1.6MG/ML) SOLUTION / INTRAVENOUS RS 2017-05-05 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base MOXIFLOXACIN HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C53598599T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351156 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 67457-323-25 MOXIFLOXACIN HYDROCHLORIDE 250 mL in 1 BAG INJECTION, SOLUTION 250 9 67457-323-25 MOXIFLOXACIN HYDROCHLORIDE 1 in 1 CARTON INJECTION, SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-323 MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240702_c6fa4129-2f92-4179-ac5d-bb7b4a538789.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 67457-323-25 67457032325 1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG 1 bag 2017-10-03 0000-00-00 No No Current