FDA.reportPublic FDA data

LOREEV XR

Product NDC
52427-661
11-digit product format
524270661
Labeler code
52427
Product ID
52427-661_1ce5f319-4e44-ae8e-b6be-ecf54a0d345a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lorazepam
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Almatica Pharma LLC
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
Rxcui2569564, 2569571, 2569573, 2569575, 2569577, 2569580, 2594600, 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
52427-661-30LOREEV XR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-661-30EA - Each52427-6618b38046b-bf36-47f9-ab74-4ef38f6ce64612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-661LOREEV XR (LORAZEPAM) CAPSULE, EXTENDED RELEASE [ALMATICA PHARMA LLC]4Current NDC, Legacy NDC, 1 package rows20241010_227734c1-bf01-9607-73ea-5a1f38a89bd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594600LORazepam 1.5 MG 24HR Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569564LORazepam 24HR 1 MG Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569573LORazepam 24HR 2 MG Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569577LORazepam 24HR 3 MG Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569571Loreev XR 1 MG 24HR Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2594603Loreev XR 1.5 MG 24HR Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569575Loreev XR 2 MG 24HR Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
2569580Loreev XR 3 MG 24HR Extended Release Oral CapsulePSN227734c1-bf01-9607-73ea-5a1f38a89bd95
256957124 HR lorazepam 1 MG Extended Release Oral Capsule [Loreev]SBD227734c1-bf01-9607-73ea-5a1f38a89bd95
259460324 HR lorazepam 1.5 MG Extended Release Oral Capsule [Loreev]SBD227734c1-bf01-9607-73ea-5a1f38a89bd95
256957524 HR lorazepam 2 MG Extended Release Oral Capsule [Loreev]SBD227734c1-bf01-9607-73ea-5a1f38a89bd95
256958024 HR lorazepam 3 MG Extended Release Oral Capsule [Loreev]SBD227734c1-bf01-9607-73ea-5a1f38a89bd95
256956424 HR lorazepam 1 MG Extended Release Oral CapsuleSCD227734c1-bf01-9607-73ea-5a1f38a89bd95
259460024 HR lorazepam 1.5 MG Extended Release Oral CapsuleSCD227734c1-bf01-9607-73ea-5a1f38a89bd95
256957324 HR lorazepam 2 MG Extended Release Oral CapsuleSCD227734c1-bf01-9607-73ea-5a1f38a89bd95
256957724 HR lorazepam 3 MG Extended Release Oral CapsuleSCD227734c1-bf01-9607-73ea-5a1f38a89bd95
259460324 HR Loreev 1.5 MG Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
256957524 HR Loreev XR 2 MG Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
256958024 HR Loreev XR 3 MG Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
2569571Loreev XR 1 MG 24 HR Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
2594603Loreev XR 1.5 MG 24 HR Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
2569575Loreev XR 2 MG 24 HR Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
2569580Loreev XR 3 MG 24 HR Extended Release Oral CapsuleSY227734c1-bf01-9607-73ea-5a1f38a89bd95
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 startMarketing endSampleExclude flagStatus
52427-661-305242706613030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-661-30) 2022-03-010000-00-00NoNoCurrent