Loxapine

Product NDC
70518-0346
11-digit product format
705180346
Labeler code
70518
Product ID
70518-0346_47e72184-a6b8-f3de-e063-6394a90a408d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loxapine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA072204
Marketing category
ANDA
Marketing start
2017-03-21
Substance
LOXAPINE SUCCINATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loxapine
Listing expiration
2027-12-31

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33eProduct name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0346-0Loxapine30 in 1 BLISTER PACKCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0346LOXAPINE CAPSULE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 1 package rows20250426_613a6459-0e61-4bed-9138-2836ff49f40b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311386loxapine succinate 5 MG Oral CapsulePSN613a6459-0e61-4bed-9138-2836ff49f40b15
311386loxapine 5 MG Oral CapsuleSCD613a6459-0e61-4bed-9138-2836ff49f40b15
311386loxapine 5 MG (as loxapine succinate 6.8 MG) Oral CapsuleSY613a6459-0e61-4bed-9138-2836ff49f40b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0346-07051803460030 CAPSULE in 1 BLISTER PACK (70518-0346-0) 30 capsule2017-03-210000-00-00NoNoCurrent