Home NDC 48792-7823-1 Moxifloxacin
Product NDC 48792-7823
Requested package NDC 48792-7823-1
11-digit product format 487927823
Labeler code 48792
Product ID 48792-7823_91509d77-9aed-afd9-e053-2995a90aae49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name moxifloxacin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sunshine Lake Pharma Co., Ltd.
Application ANDA206295
Marketing category ANDA
Marketing start 2018-10-12
Marketing end 0000-00-00
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 400 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206295-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 2018-09-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A206295-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206295-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206295-001 AB 1 a50c72e98297…
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 48792-7823-1 48792782301 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7823-1) 2018-10-12 0000-00-00 No No Current