MOXIFLOXACIN HYDROCHLORIDE

Product NDC
70518-3738
11-digit product format
705183738
Labeler code
70518
Product ID
70518-3738_5217ad4c-ce24-c036-e063-6394a90abd2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202632
Marketing category
ANDA
Marketing start
2023-05-30
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202632-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202632-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043f01610625f2…
2019-09-15 20:21 UTC2019-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202632-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202632-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202632-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202632-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202632-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202632-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202632-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202632-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202632-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202632-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202632-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202632-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202632-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202632-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202632-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202632-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202632-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202632-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202632-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202632-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202632-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202632-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202632-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202632-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202632-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202632-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202632-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202632-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202632-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202632-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202632-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202632-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202632-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202632-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202632-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202632-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202632-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202632-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202632-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202632-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
MOXIFLOXACIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C53598599TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311787Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd0c0690-ba48-41c5-b76b-b1a53c36f424Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3738-0MOXIFLOXACIN HYDROCHLORIDE7 in 1 BOTTLE, PLASTICTABLET, FILM COATED79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3738MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, 1 package rows20250215_bd0c0690-ba48-41c5-b76b-b1a53c36f424.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAmerican Health Packaging1ed191f5-7df5-488c-bb72-91ac0b618d9a2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.bd0c0690-ba48-41c5-b76b-b1a53c36f4242026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 70518-3738
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAvPAK371ca7b2-c62d-ef4b-3076-890b385bfff82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be5b7a6f-9ee3-4453-807e-4761fffff60c2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a98b20d-c4a1-4184-8387-a4866d1d62bf2026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.18b77b31-baf3-416f-b3b7-a631c8e46d202026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepack6cd420c3-113e-4fc2-b59f-bfc7c485c14d2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMajor Pharmaceuticals815d71cf-02de-4190-9bd1-3fdc67ef0f062025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac8a81b9-2fed-412a-8c83-db8dee1061f62025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERising Pharma Holdings, Inc.f34c08e6-fe74-4de3-9e36-a82c3c1c183b2025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions37466c79-8726-4fd6-9412-0bb83d523fe32025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEAurobindo Pharma Limitedd6789c17-4a2f-4519-9060-e3b0dba422f02025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.54377276-96bf-4140-9e90-55623ab6b0132025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions02c29e8e-8346-4e28-b7fc-2f4cb61ad37d2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutionsc71e5987-edd7-4c38-b646-3e48a6e51bf42023-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSNbd0c0690-ba48-41c5-b76b-b1a53c36f4249
311787moxifloxacin 400 MG Oral TabletSCDbd0c0690-ba48-41c5-b76b-b1a53c36f4249
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYbd0c0690-ba48-41c5-b76b-b1a53c36f4249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3738-0705183738007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3738-0) 2023-05-30NoNoCurrent