Loxapine

Product NDC
0527-1395
11-digit product format
005271395
Labeler code
0527
Product ID
0527-1395_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
10 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 SUCCINATE10 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
0527-1395-01Loxapine100 in 1 BOTTLE, PLASTICCAPSULE10020
0527-1395-10Loxapine1000 in 1 BOTTLE, PLASTICCAPSULE100020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1395LOXAPINE 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
314078loxapine succinate 10 MG Oral CapsulePSN74ac619f-216b-4a79-b23a-158f4e44d25d16
314078loxapine 10 MG Oral CapsuleSCD74ac619f-216b-4a79-b23a-158f4e44d25d16
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSY74ac619f-216b-4a79-b23a-158f4e44d25d16
314078loxapine succinate 10 MG Oral CapsulePSN2ce01a5d-b9bc-af4d-e063-6394a90af9e41
314078loxapine 10 MG Oral CapsuleSCD2ce01a5d-b9bc-af4d-e063-6394a90af9e41
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSY2ce01a5d-b9bc-af4d-e063-6394a90af9e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1395-0100527139501100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1395-01) 100 capsule2011-09-260000-00-00NoNoCurrent
0527-1395-10005271395101000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1395-10) 1000 capsule2011-09-260000-00-00NoNoCurrent