Home NDC 62135-014 Moxifloxacin
Product NDC 62135-014
11-digit product format 621350014
Labeler code 62135
Product ID 62135-014_59428a91-3a88-2e83-e063-6294a90a3cef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxifloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA207285
Marketing category ANDA
Marketing start 2017-02-13
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 43 .
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 A207285-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207285-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207285-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-02-13 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Moxifloxacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
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 311787 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-014-30 62135001430 30 TABLET, FILM COATED in 1 BOTTLE (62135-014-30) 2026-08-11 No No Current