FDA.reportPublic FDA data

Loxapine

Product NDC
0527-1397
11-digit product format
005271397
Labeler code
0527
Product ID
0527-1397_d237714b-55f8-4a6e-9297-c10d41ab3cd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA090695
Marketing category
ANDA
Marketing start
2011-09-26
Substance
LOXAPINE SUCCINATE
Active strength
50 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 SUCCINATE50 mg/1

Harmonized Identifiers#

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

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
0527-1397-01Loxapine100 in 1 BOTTLE, PLASTICCAPSULE10020
0527-1397-10Loxapine1000 in 1 BOTTLE, PLASTICCAPSULE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1397-01EA - Each0527-1397c7bc2786-d4a8-4578-9970-f91357b546e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOXAPINE SUCCINATEACTIVE INGREDIENTX59SG0MRYULOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
LOXAPINEACTIVE MOIETYLER583670JLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1ULOXAPINE CAPSULE [LANNETT COMPANY, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOXAPINE CAPSULE [LANNETT COMPANY, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1397LOXAPINE CAPSULE [LANNETT COMPANY, INC.]20Current NDC, Legacy NDC, 2 package rows20241120_509bad3c-b563-4042-b270-d28bde19f224.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314078loxapine succinate 10 MG Oral CapsulePSN509bad3c-b563-4042-b270-d28bde19f22420
311385loxapine succinate 25 MG Oral CapsulePSN509bad3c-b563-4042-b270-d28bde19f22420
311386loxapine succinate 5 MG Oral CapsulePSN509bad3c-b563-4042-b270-d28bde19f22420
314075loxapine succinate 50 MG Oral CapsulePSN509bad3c-b563-4042-b270-d28bde19f22420
314078loxapine 10 MG Oral CapsuleSCD509bad3c-b563-4042-b270-d28bde19f22420
311385loxapine 25 MG Oral CapsuleSCD509bad3c-b563-4042-b270-d28bde19f22420
311386loxapine 5 MG Oral CapsuleSCD509bad3c-b563-4042-b270-d28bde19f22420
314075loxapine 50 MG Oral CapsuleSCD509bad3c-b563-4042-b270-d28bde19f22420
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSY509bad3c-b563-4042-b270-d28bde19f22420
311385loxapine 25 MG (as loxapine succinate 34 MG) Oral CapsuleSY509bad3c-b563-4042-b270-d28bde19f22420
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY509bad3c-b563-4042-b270-d28bde19f22420
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSY509bad3c-b563-4042-b270-d28bde19f22420
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
314075loxapine succinate 50 MG Oral CapsulePSN9422b8f2-24cc-4387-acf1-f663dacb613c1
314075loxapine 50 MG Oral CapsuleSCD9422b8f2-24cc-4387-acf1-f663dacb613c1
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSY9422b8f2-24cc-4387-acf1-f663dacb613c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1397-0100527139701100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1397-01) 100 capsule2011-09-260000-00-00NoNoCurrent
0527-1397-10005271397101000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1397-10) 1000 capsule2011-09-260000-00-00NoNoCurrent