Home NDC 81033-068 Moxifloxacin
Product NDC 81033-068
11-digit product format 810330068
Labeler code 81033
Product ID 81033-068_5a6d3ff1-e854-a3d8-e063-6394a90a18f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name moxifloxacin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kesin Pharma Corportation
Application ANDA206295
Marketing category ANDA
Marketing start 2025-12-12
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 400 mg/1
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 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 A206295-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206295-001 AB
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 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2018-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 3a93d1ddd44b…
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 Moxifloxacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Moxifloxacin MOXIFLOXACIN HYDROCHLORIDE Solaris Pharma Corporation 45ce14e5-98b8-296b-e063-6294a90a769b 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206295 application number: ANDA206295