FDA.reportPublic FDA data

Loxapine

Product NDC
0591-0369
11-digit product format
005910369
Labeler code
0591
Product ID
0591-0369_cae2db34-6be2-45cf-b9b5-9b929650eb4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072204
Marketing category
ANDA
Marketing start
1988-06-15
Substance
LOXAPINE SUCCINATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loxapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOXAPINE SUCCINATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX59SG0MRYU
Rxcui311385, 311386, 314075, 314078

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0369-01Loxapine100 in 1 BOTTLE, PLASTICCAPSULE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0369-01EA - Each0591-0369af9a21b2-4ec5-48bf-82e6-92ff40da77d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOXAPINE SUCCINATEACTIVE INGREDIENTX59SG0MRYULOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
LOXAPINEACTIVE MOIETYLER583670JLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
GELATININACTIVE INGREDIENT2G86QN327LLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1ULOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOXAPINE CAPSULE [WATSON LABORATORIES, INC.]13
LOXAPINE SUCCINATEACTIVE INGREDIENTX59SG0MRYULOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
LOXAPINEACTIVE MOIETYLER583670JLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0369LOXAPINE CAPSULE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20250326_a6107bb1-3e23-4c5d-bbf4-5e29deff6728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314078loxapine succinate 10 MG Oral CapsulePSNa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311385loxapine succinate 25 MG Oral CapsulePSNa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311386loxapine succinate 5 MG Oral CapsulePSNa6107bb1-3e23-4c5d-bbf4-5e29deff672820
314075loxapine succinate 50 MG Oral CapsulePSNa6107bb1-3e23-4c5d-bbf4-5e29deff672820
314078loxapine 10 MG Oral CapsuleSCDa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311385loxapine 25 MG Oral CapsuleSCDa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311386loxapine 5 MG Oral CapsuleSCDa6107bb1-3e23-4c5d-bbf4-5e29deff672820
314075loxapine 50 MG Oral CapsuleSCDa6107bb1-3e23-4c5d-bbf4-5e29deff672820
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSYa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311385loxapine 25 MG (as loxapine succinate 34 MG) Oral CapsuleSYa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSYa6107bb1-3e23-4c5d-bbf4-5e29deff672820
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSYa6107bb1-3e23-4c5d-bbf4-5e29deff672820
311386loxapine succinate 5 MG Oral CapsulePSN613a6459-0e61-4bed-9138-2836ff49f40b15
311386loxapine 5 MG Oral CapsuleSCD613a6459-0e61-4bed-9138-2836ff49f40b15
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY613a6459-0e61-4bed-9138-2836ff49f40b15
311386loxapine succinate 5 MG Oral CapsulePSN337bb945-64b9-4da5-8c10-1aead291c1842
311386loxapine 5 MG Oral CapsuleSCD337bb945-64b9-4da5-8c10-1aead291c1842
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY337bb945-64b9-4da5-8c10-1aead291c1842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0369-0100591036901100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0369-01) 100 capsule1988-06-150000-00-00NoNoCurrent