Loxapine

Product NDC
62135-493
11-digit product format
621350493
Labeler code
62135
Product ID
62135-493_456ed50c-28f9-4af8-e063-6394a90a23f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
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
Rxcui311386, 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
62135-493-60Loxapine60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-493LOXAPINE CAPSULE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241013_3e412c36-66b0-444b-833b-cea79976844e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314078loxapine succinate 10 MG Oral CapsulePSN3e412c36-66b0-444b-833b-cea79976844e3
311386loxapine succinate 5 MG Oral CapsulePSN3e412c36-66b0-444b-833b-cea79976844e3
314078loxapine 10 MG Oral CapsuleSCD3e412c36-66b0-444b-833b-cea79976844e3
311386loxapine 5 MG Oral CapsuleSCD3e412c36-66b0-444b-833b-cea79976844e3
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSY3e412c36-66b0-444b-833b-cea79976844e3
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY3e412c36-66b0-444b-833b-cea79976844e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-493-606213504936060 CAPSULE in 1 BOTTLE (62135-493-60) 60 capsule2023-03-01NoNoCurrent