Loxapine

Product NDC
0378-7050
11-digit product format
003787050
Labeler code
0378
Product ID
0378-7050_500e424b-5d74-4d48-80b7-2ea6c97fc91b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076762
Marketing category
ANDA
Marketing start
2004-11-03
Marketing end
0000-00-00
Substance
LOXAPINE SUCCINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct0378-7050DDiscontinued by firm2026-08-10
excluded packagepackage0378-70500378-7050-01DDiscontinued 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 · 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 packagepackage0378-7050-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-7050-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-7050-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-7050-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-7050-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-7050-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-7050-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-7050-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-7050-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-7050-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-7050-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-7050-01557ba5c1ecfa…9c80585c8c6e…

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
A076762-001LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01
A076762-002LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01
A076762-003LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01
A076762-004LOXAPINE SUCCINATELOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01

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 UTC2026-02A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076762-001LOXAPINE SUCCINATEEQ 5MG BASECAPSULE / ORAL2004-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076762-002LOXAPINE SUCCINATEEQ 10MG BASECAPSULE / ORAL2004-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076762-003LOXAPINE SUCCINATEEQ 25MG BASECAPSULE / ORAL2004-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A076762-004LOXAPINE SUCCINATEEQ 50MG BASECAPSULE / ORAL2004-11-01d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076762-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076762-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076762-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076762-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076762-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076762-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076762-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076762-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076762-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076762-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076762-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076762-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076762-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076762-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076762-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076762-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076762-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076762-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076762-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076762-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076762-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076762-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076762-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076762-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076762-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076762-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076762-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076762-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076762-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076762-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076762-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076762-004AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7050-01EA - Each0378-7050361ea014-ae6e-493e-8b9a-ae9465746f3412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOXAPINE SUCCINATEACTIVE INGREDIENTX59SG0MRYULOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LOXAPINEACTIVE MOIETYLER583670JLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOXAPINE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LOXAPINE SUCCINATEACTIVE INGREDIENTX59SG0MRYULOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
LOXAPINEACTIVE MOIETYLER583670JLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOXAPINE CAPSULE [MYLAN INSTITUTIONAL INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7050-0100378705001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7050-01) 100 capsule2004-11-030000-00-00NoNoCurrent