Loxapine

Product NDC
35573-437
Requested package NDC
35573-437-02
11-digit product format
355730437
Labeler code
35573
Product ID
35573-437_8beb166a-d8f6-4b77-b191-3d7f5699a6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA076868
Marketing category
ANDA
Marketing start
2021-05-01
Marketing end
0000-00-00
Substance
LOXAPINE SUCCINATE
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35573-43735573-437-02DDiscontinued 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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
A076868-001LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04
A076868-002LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04
A076868-003LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04
A076868-004LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076868-001AB
A076868-002AB
A076868-003AB
A076868-004AB

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 UTC2026-02A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076868-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORALAB2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORALAB2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORALAB2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORALAB2005-08-04d06236e962d9…

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 UTC2026-02A076868-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076868-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076868-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076868-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076868-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076868-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076868-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076868-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076868-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076868-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076868-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076868-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076868-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-437-02EA - Each35573-43716b9703b-9448-4872-a7b6-a50e1f8766d412021-06-02

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoxapineLOXAPINEREMEDYREPACK INC.ce8c5a31-7600-4525-a0c7-b3adc9ec29772025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076868
application number: ANDA076868
LoxapineLOXAPINEElite Laboratories, Inc.a0cc7bb6-075f-47d1-8935-eb77a29d8c452025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076868
application number: ANDA076868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-437-0235573043702100 CAPSULE in 1 BOTTLE (35573-437-02) 100 capsule2021-05-010000-00-00NoNoCurrent