Home NDC 55111-112 Moxifloxacin
Product NDC 55111-112
11-digit product format 551110112
Labeler code 55111
Product ID 55111-112_b7966736-4865-d3ad-d218-886c8a286492
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxifloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA076938
Marketing category ANDA
Marketing start 2014-03-05
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 400 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC], Quinolones [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 A076938-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076938-001 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 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2014-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2014-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2014-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB 2014-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076938-001 MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL AB RS 2014-03-04 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
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55111-112-01 Moxifloxacin 100 in 1 BOTTLE TABLET, FILM COATED 100 16 55111-112-05 Moxifloxacin 500 in 1 BOTTLE TABLET, FILM COATED 500 16 55111-112-30 Moxifloxacin 30 in 1 BOTTLE TABLET, FILM COATED 30 16 55111-112-66 Moxifloxacin 5 in 1 CARTON TABLET, FILM COATED 5 16 55111-112-79 Moxifloxacin 10 in 1 BLISTER PACK TABLET, FILM COATED 10 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MOXIFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT C53598599T MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 MOXIFLOXACIN ACTIVE MOIETY U188XYD42P MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 MOXIFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT C53598599T MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 MOXIFLOXACIN ACTIVE MOIETY U188XYD42P MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-112 MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 16 Current NDC, Legacy NDC, 5 package rows 20210203_71b02da1-3175-1db8-192a-c0a8a6cd98a5.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.
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 55111-112-01 55111011201 100 TABLET, FILM COATED in 1 BOTTLE (55111-112-01) 2014-03-05 0000-00-00 No No Current 55111-112-05 55111011205 500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05) 2014-03-05 0000-00-00 No No Current 55111-112-30 55111011230 30 TABLET, FILM COATED in 1 BOTTLE (55111-112-30) 2014-03-05 0000-00-00 No No Current 55111-112-66 55111011266 5 BLISTER PACK in 1 CARTON (55111-112-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-112-79) 5 blister pack 2014-03-05 0000-00-00 No No Current 55111-112-79 55111011279 10 in 1 BLISTER PACK Historical