FDA.reportPublic FDA data

Loxapine

Product NDC
82804-051
11-digit product format
828040051
Labeler code
82804
Product ID
82804-051_3fa7b9c3-f500-49d5-b0c5-27ff01779713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090695
Marketing category
ANDA
Marketing start
2011-09-26
Substance
LOXAPINE SUCCINATE
Active strength
5 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 SUCCINATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX59SG0MRYU
Rxcui311386

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
82804-051-30Loxapine30 in 1 BOTTLE, PLASTICCAPSULE301
82804-051-60Loxapine60 in 1 BOTTLE, PLASTICCAPSULE601
82804-051-90Loxapine90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-051-30EA - Each82804-0517bc9fb82-34a2-4790-8963-fdbf6d6dd64b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-051LOXAPINE CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20231223_3fa7b9c3-f500-49d5-b0c5-27ff01779713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311386loxapine succinate 5 MG Oral CapsulePSN3fa7b9c3-f500-49d5-b0c5-27ff017797131
311386loxapine 5 MG Oral CapsuleSCD3fa7b9c3-f500-49d5-b0c5-27ff017797131
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY3fa7b9c3-f500-49d5-b0c5-27ff017797131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-051-308280400513030 CAPSULE in 1 BOTTLE, PLASTIC (82804-051-30) 30 capsule2023-12-01NoNoCurrent
82804-051-608280400516060 CAPSULE in 1 BOTTLE, PLASTIC (82804-051-60) 60 capsule2023-12-01NoNoCurrent
82804-051-908280400519090 CAPSULE in 1 BOTTLE, PLASTIC (82804-051-90) 90 capsule2023-12-01NoNoCurrent