Loxapine

Product NDC
67046-1478
11-digit product format
670461478
Labeler code
67046
Product ID
67046-1478_2cf84def-bf5d-9564-e063-6394a90a9b03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA090695
Marketing category
ANDA
Marketing start
2025-01-30
Substance
LOXAPINE SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX59SG0MRYU
Rxcui311385

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
67046-1478-3Loxapine30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1478LOXAPINE CAPSULE [COUPLER LLC]1Current NDC, 1 package rows20250201_2cf85ba7-7b62-6519-e063-6394a90a32c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311385loxapine succinate 25 MG Oral CapsulePSN2cf85ba7-7b62-6519-e063-6394a90a32c41
311385loxapine 25 MG Oral CapsuleSCD2cf85ba7-7b62-6519-e063-6394a90a32c41
311385loxapine 25 MG (as loxapine succinate 34 MG) Oral CapsuleSY2cf85ba7-7b62-6519-e063-6394a90a32c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1478-36704614780330 CAPSULE in 1 BLISTER PACK (67046-1478-3) 30 capsule2025-01-30NoNoCurrent