Loxapine

Product NDC
70518-2120
11-digit product format
705182120
Labeler code
70518
Product ID
70518-2120_c6244a20-ce78-2179-e053-2995a90a6751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090695
Marketing category
ANDA
Marketing start
2019-05-28
Marketing end
0000-00-00
Substance
LOXAPINE SUCCINATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2120DDiscontinued by firm2026-08-17
excluded packagepackage70518-212070518-2120-0DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2120-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2120-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2120-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2120-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2120-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2120-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2120-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2120-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2120-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2120-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2120-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2120-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090695-001LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26
A090695-002LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26
A090695-003LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26
A090695-004LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090695-001AB
A090695-002AB
A090695-003AB
A090695-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090695-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090695-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090695-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090695-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090695-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090695-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090695-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090695-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090695-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090695-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090695-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090695-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090695-004AB1d8e5a09893c0…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2120-02023-03-07C16284748780-1f386c64a-2915-0266-e053-dadaa90a7c1aLoxapine Capsules, USP
70518-2120-02023-01-30C16284748780-1f386c64a-2915-0266-e053-dadaa90a7c1aLoxapine Capsules, USP

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoxapineLOXAPINEREMEDYREPACK INC.832ce6b1-5846-4a5b-adb4-ac4e0f502d782026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINEREMEDYREPACK INC.2d45dd3c-71c3-4cc1-92ac-6dcecb195dd22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINEREMEDYREPACK INC.74ac619f-216b-4a79-b23a-158f4e44d25d2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINEChartwell RX, LLC3e412c36-66b0-444b-833b-cea79976844e2025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINECoupler LLC2cf83a3e-d76d-2a1f-e063-6294a90aa6bc2025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINECoupler LLC2cf85ba7-7b62-6519-e063-6394a90a32c42025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINECoupler LLC2ce01a5d-b9bc-af4d-e063-6394a90af9e42025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINELannett Company, Inc.509bad3c-b563-4042-b270-d28bde19f2242024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695
LoxapineLOXAPINEProficient Rx LP3fa7b9c3-f500-49d5-b0c5-27ff017797132023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090695
application number: ANDA090695

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2120-07051821200030 CAPSULE in 1 BLISTER PACK (70518-2120-0) 30 capsule2019-05-280000-00-00NoNoCurrent