FDA.reportPublic FDA data

LOREEV XR

Product NDC
50090-7592
11-digit product format
500907592
Labeler code
50090
Product ID
50090-7592_797bc295-d908-4740-b496-c87e19b0eca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lorazepam
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA214826
Marketing category
NDA
Marketing start
2022-03-01
Substance
LORAZEPAM
Active strength
1.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOREEV XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui2594600, 2594603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a759f740-8682-4896-9194-8b6c103c9aeeProduct name320250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1Product name120220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285Product name220180320
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7592-0LOREEV XR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7592-0EA - Each50090-7592e5602a24-f4d9-450c-a460-b710099084ab12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594600LORazepam 1.5 MG 24HR Extended Release Oral CapsulePSNc470fdee-8e18-4da9-b072-943d6b2518cf1
2594603Loreev XR 1.5 MG 24HR Extended Release Oral CapsulePSNc470fdee-8e18-4da9-b072-943d6b2518cf1
259460324 HR lorazepam 1.5 MG Extended Release Oral Capsule [Loreev]SBDc470fdee-8e18-4da9-b072-943d6b2518cf1
259460024 HR lorazepam 1.5 MG Extended Release Oral CapsuleSCDc470fdee-8e18-4da9-b072-943d6b2518cf1
259460324 HR Loreev 1.5 MG Extended Release Oral CapsuleSYc470fdee-8e18-4da9-b072-943d6b2518cf1
2594603Loreev XR 1.5 MG 24 HR Extended Release Oral CapsuleSYc470fdee-8e18-4da9-b072-943d6b2518cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7592-05009075920030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-7592-0) 2025-07-02NoNoHistorical