LOREEV XR
- Product NDC
- 52427-663
- 11-digit product format
- 524270663
- Labeler code
- 52427
- Product ID
- 52427-663_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
- 2021-08-31
- Substance
- LORAZEPAM
- Active strength
- 2 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 |
|---|---|
| LORAZEPAM | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | O26FZP769L |
| Rxcui | 2569564, 2569571, 2569573, 2569575, 2569577, 2569580, 2594600, 2594603 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a759f740-8682-4896-9194-8b6c103c9aee | Product name | 3 | 20250716 |
| b7badb1c-6d3f-4f95-a4ca-ce69992e58a1 | Product name | 1 | 20220308 |
| 5d98a0ba-a64b-d9b2-e6ec-87edbb57a285 | Product name | 2 | 20180320 |
| ac8efea8-f412-295f-00ce-b095e5cbc115 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52427-663-30 | LOREEV XR | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52427-663-30 | EA - Each | 52427-663 | 47b0ed58-ef12-492e-be34-ee382e750c5f | 1 | 2021-10-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2594600 | LORazepam 1.5 MG 24HR Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569564 | LORazepam 24HR 1 MG Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569573 | LORazepam 24HR 2 MG Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569577 | LORazepam 24HR 3 MG Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569571 | Loreev XR 1 MG 24HR Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2594603 | Loreev XR 1.5 MG 24HR Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569575 | Loreev XR 2 MG 24HR Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569580 | Loreev XR 3 MG 24HR Extended Release Oral Capsule | PSN | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569571 | 24 HR lorazepam 1 MG Extended Release Oral Capsule [Loreev] | SBD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2594603 | 24 HR lorazepam 1.5 MG Extended Release Oral Capsule [Loreev] | SBD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569575 | 24 HR lorazepam 2 MG Extended Release Oral Capsule [Loreev] | SBD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569580 | 24 HR lorazepam 3 MG Extended Release Oral Capsule [Loreev] | SBD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569564 | 24 HR lorazepam 1 MG Extended Release Oral Capsule | SCD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2594600 | 24 HR lorazepam 1.5 MG Extended Release Oral Capsule | SCD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569573 | 24 HR lorazepam 2 MG Extended Release Oral Capsule | SCD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569577 | 24 HR lorazepam 3 MG Extended Release Oral Capsule | SCD | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2594603 | 24 HR Loreev 1.5 MG Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569575 | 24 HR Loreev XR 2 MG Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569580 | 24 HR Loreev XR 3 MG Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569571 | Loreev XR 1 MG 24 HR Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2594603 | Loreev XR 1.5 MG 24 HR Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569575 | Loreev XR 2 MG 24 HR Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
| 2569580 | Loreev XR 3 MG 24 HR Extended Release Oral Capsule | SY | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52427-663-30 | 52427066330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-663-30) | 2021-09-24 | 0000-00-00 | No | No | Current |