Loxapine

Product NDC
0591-0370
11-digit product format
005910370
Labeler code
0591
Product ID
0591-0370_cae2db34-6be2-45cf-b9b5-9b929650eb4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072205
Marketing category
ANDA
Marketing start
1988-06-15
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0370-01Loxapine100 in 1 BOTTLE, PLASTICCAPSULE10020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0370LOXAPINE 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0370-000059103700075200 CAPSULE in 1 BAG (0591-0370-00)75200 capsule15-JUN-88Current
0591-0370-0100591037001100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0370-01) 100 capsule1988-06-150000-00-00NoNoCurrent