Home NDC 72789-080 Moxifloxacin Hydrochloride Tablets, 400 mg
Product NDC 72789-080
11-digit product format 727890080
Labeler code 72789
Product ID 72789-080_40319333-cf76-1664-e063-6294a90ae7e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxifloxacin Hydrochloride Tablets, 400 mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA208682
Marketing category ANDA
Marketing start 2018-07-21
Substance MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength 400 mg/1
Pharmacologic classes Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A208682-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208682-001 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 · 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 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208682-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2017-09-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Moxifloxacin Hydrochloride Tablets, 400 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B8956S8609 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-080-10 Moxifloxacin Hydrochloride Tablets, 400 mg 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-080 MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241010_5c2a9116-d6e4-429e-88bb-bb6bfedac2f0.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Moxifloxacin Hydrochloride Tablets, 400 mg MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG REMEDYREPACK INC. bdb3f89a-01e7-411d-b071-48e87def0873 2025-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208682 application number: ANDA208682 Moxifloxacin Hydrochloride Tablets, 400 mg MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG PD-Rx Pharmaceuticals, Inc. 5c2a9116-d6e4-429e-88bb-bb6bfedac2f0 2025-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208682 application number: ANDA208682 ndc (product): 72789-080 Moxifloxacin Hydrochloride Tablets, 400 mg MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG Novadoz Pharmaceuticals LLC 04e0936f-2248-48e4-8031-ac6ccc2df294 2019-04-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208682 application number: ANDA208682
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72789-080-10 72789008010 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10) 2020-04-10 0000-00-00 No No Current