Prescription drug · NDA
Loreev XR (Lorazepam) NDC 52427-658
Lorazepam 1 mg/1 · Capsule, Extended release · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-658-30 | 5242706583052427065830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30)Marketed from Sep 24, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Loreev XR
- Generic name (nonproprietary)
- lorazepam
- Active ingredients
- Lorazepam — 1 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Almatica Pharma LLCNDC labeler code 52427
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214826
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 52427-658_fa403ae4-25fa-9fb8-1596-342d4560c6daSPL ID fa403ae4-25fa-9fb8-1596-342d4560c6da
- Pharmacologic class
- Benzodiazepine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452427065830followed by a unit qualifier and the quantityPackage 52427-0658-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 52427-658
- What is NDC 52427-658?
- 52427-658 is the product NDC for Loreev XR (lorazepam), Lorazepam 1 mg/1 capsule, extended release, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loreev XR (Lorazepam).
- What is the active ingredient?
- Lorazepam.
- Who is the labeler?
- Almatica Pharma LLC, NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loreev XR?
- 4 other product NDCs are listed under this name. See all Loreev XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loreev XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loreev XRlorazepam | Lorazepam 1.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7592 | 50090-7592-00 |
| Loreev XRlorazepam | Lorazepam 1.5 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-661 | 52427-0661-30 |
| Loreev XRlorazepam | Lorazepam 2 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-663 | 52427-0663-30 |
| Loreev XRlorazepam | Lorazepam 3 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-667 | 52427-0667-30 |
Other NDCs under NDA 214826
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Loreev XRlorazepam | Lorazepam 1.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7592 |
| Loreev XRlorazepam | Lorazepam 1.5 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-661 |
| Loreev XRlorazepam | Lorazepam 2 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-663 |
| Loreev XRlorazepam | Lorazepam 3 mg/1 | Capsule, Extended releaseOral | Almatica Pharma LLC | 52427-667 |