Loxapine

Product NDC
64850-891
11-digit product format
648500891
Labeler code
64850
Product ID
64850-891_538b7d03-c464-465d-b690-9701c14cf580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Elite Laboratories, Inc.
Application
ANDA076868
Marketing category
ANDA
Marketing start
2020-01-27
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
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64850-891-01Loxapine100 in 1 BOTTLECAPSULE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-891LOXAPINE CAPSULE [ELITE LABORATORIES, INC.]8Current NDC, Legacy NDC, 1 package rows20250303_a0cc7bb6-075f-47d1-8935-eb77a29d8c45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314078loxapine succinate 10 MG Oral CapsulePSNa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311385loxapine succinate 25 MG Oral CapsulePSNa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311386loxapine succinate 5 MG Oral CapsulePSNa0cc7bb6-075f-47d1-8935-eb77a29d8c458
314075loxapine succinate 50 MG Oral CapsulePSNa0cc7bb6-075f-47d1-8935-eb77a29d8c458
314078loxapine 10 MG Oral CapsuleSCDa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311385loxapine 25 MG Oral CapsuleSCDa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311386loxapine 5 MG Oral CapsuleSCDa0cc7bb6-075f-47d1-8935-eb77a29d8c458
314075loxapine 50 MG Oral CapsuleSCDa0cc7bb6-075f-47d1-8935-eb77a29d8c458
314078loxapine 10 MG (as loxapine succinate 13.6 MG) Oral CapsuleSYa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311385loxapine 25 MG (as loxapine succinate 34 MG) Oral CapsuleSYa0cc7bb6-075f-47d1-8935-eb77a29d8c458
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSYa0cc7bb6-075f-47d1-8935-eb77a29d8c458
314075loxapine 50 MG (as loxapine succinate 68.1 MG) Oral CapsuleSYa0cc7bb6-075f-47d1-8935-eb77a29d8c458

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64850-891-0164850089101100 CAPSULE in 1 BOTTLE (64850-891-01) 100 capsule2020-01-270000-00-00NoNoCurrent