Loxapine

Product NDC
70518-4311
11-digit product format
705184311
Labeler code
70518
Product ID
70518-4311_402dc434-9e39-e95d-e063-6294a90acc06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076868
Marketing category
ANDA
Marketing start
2025-03-17
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
Rxcui314075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4311-0Loxapine30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4311LOXAPINE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20250321_ce8c5a31-7600-4525-a0c7-b3adc9ec2977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314075loxapine succinate 50 MG Oral CapsulePSNce8c5a31-7600-4525-a0c7-b3adc9ec29772
314075loxapine 50 MG Oral CapsuleSCDce8c5a31-7600-4525-a0c7-b3adc9ec29772
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSYce8c5a31-7600-4525-a0c7-b3adc9ec29772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4311-07051843110030 CAPSULE in 1 BLISTER PACK (70518-4311-0) 30 capsule2025-03-17NoNoCurrent