Loxapine

Product NDC
70518-1792
11-digit product format
705181792
Labeler code
70518
Product ID
70518-1792_4aa50495-d1b1-74af-e063-6394a90a6f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090695
Marketing category
ANDA
Marketing start
2019-01-11
Substance
LOXAPINE SUCCINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-179270518-1792-2DDiscontinued by firm2026-08-10

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-1792-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-1792-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-1792-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-1792-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-1792-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-1792-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-1792-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-1792-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-1792-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-1792-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-1792-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-1792-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-1792-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-1792-1367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A090695-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2011-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2011-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2011-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2011-09-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A090695-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090695-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOXAPINE SUCCINATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X59SG0MRYUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314075Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1792-0Loxapine1 in 1 POUCHCAPSULE115
70518-1792-1Loxapine100 in 1 BOXCAPSULE10015
70518-1792-2Loxapine30 in 1 BLISTER PACKCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1792LOXAPINE CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250131_2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2.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 · 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
ndc (product): 70518-1792
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314075loxapine succinate 50 MG Oral CapsulePSN2d45dd3c-71c3-4cc1-92ac-6dcecb195dd215
314075loxapine 50 MG Oral CapsuleSCD2d45dd3c-71c3-4cc1-92ac-6dcecb195dd215
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSY2d45dd3c-71c3-4cc1-92ac-6dcecb195dd215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1792-0705181792001 CAPSULE in 1 POUCH (70518-1792-0) 1 capsule2019-01-110000-00-00NoNoCurrent
70518-1792-170518179201100 CAPSULE in 1 BOX (70518-1792-1) 100 capsule2019-02-080000-00-00NoNoCurrent
70518-1792-27051817920230 in 1 BLISTER PACKHistorical