Prescription drug · NDA
Lumryz (Sodium oxybate) NDC 13551-004
Sodium oxybate 9 g/1 · For suspension, Extended release · Oral · Alkermes, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13551-004-07 | 1355100040713551000407 | 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKETMarketed from May 1, 2023 | |
| 13551-004-30 | 1355100043013551000430 | 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKETMarketed from May 1, 2023 |
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)
- Lumryz
- Generic name (nonproprietary)
- sodium oxybate
- Active ingredients
- Sodium oxybate — 9 g/1
- Dosage form
- For suspension, Extended release
- Route
- Oral
- Labeler
- Alkermes, Inc.NDC labeler code 13551
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214755
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 13551-004_0aae7705-0d32-4900-8233-0b3da243bed6SPL ID 0aae7705-0d32-4900-8233-0b3da243bed6
- Pharmacologic class
- Central Nervous System Depressant
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
N413551000407followed by a unit qualifier and the quantityPackage 13551-0004-07. 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 13551-004
- What is NDC 13551-004?
- 13551-004 is the product NDC for Lumryz (sodium oxybate), Sodium oxybate 9 g/1 for suspension, extended release, listed with the FDA by Alkermes, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lumryz (Sodium oxybate).
- What is the active ingredient?
- Sodium oxybate.
- Who is the labeler?
- Alkermes, Inc., NDC labeler code 13551. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lumryz?
- 4 other product NDCs are listed under this name. See all Lumryz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lumryz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lumryzsodium oxybate | — | Kit | Alkermes, Inc. | 13551-005 | 13551-0005-01 |
| Lumryzsodium oxybate | Sodium oxybate 4.5 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-001 | 13551-0001-0713551-0001-30 |
| Lumryzsodium oxybate | Sodium oxybate 6 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-002 | 13551-0002-0713551-0002-30 |
| Lumryzsodium oxybate | Sodium oxybate 7.5 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-003 | 13551-0003-0713551-0003-30 |
Other NDCs under NDA 214755
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 |
|---|---|---|---|---|
| Lumryzsodium oxybate | Sodium oxybate 4.5 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-001 |
| Lumryzsodium oxybate | Sodium oxybate 6 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-002 |
| Lumryzsodium oxybate | Sodium oxybate 7.5 g/1 | For suspension, Extended releaseOral | Alkermes, Inc. | 13551-003 |
| Lumryzsodium oxybate | — | Kit | Alkermes, Inc. | 13551-005 |