Prescription drug · NDA
Oxlumo (Lumasiran) NDC 71336-1002
Lumasiran sodium 94.5 mg/.5mL · Injection, Solution · Subcutaneous · Alnylam Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71336-1002-1 | 71336100201 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USEMarketed from Nov 23, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Oxlumo
- Generic name (nonproprietary)
- lumasiran
- Active ingredients
- Lumasiran sodium — 94.5 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Alnylam Pharmaceuticals, Inc.NDC labeler code 71336
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214103
- Marketing start
- Listing expires
- Identifiers
- Product ID 71336-1002_6ef869cb-8ccd-4339-9991-0fab45da1fbdSPL ID 6ef869cb-8ccd-4339-9991-0fab45da1fbdSPL set ID 16985a31-f5e4-4557-9266-fc78d4bc5055RxCUI 2467153, 2467158UNII 67P6XH37HD
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471336100201followed by a unit qualifier and the quantityPackage 71336-1002-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1) , Clinical Studies (14.1 , 14.2 , 14.3) ] . OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71336-1002
- What is NDC 71336-1002?
- 71336-1002 is the product NDC for Oxlumo (lumasiran), Lumasiran sodium 94.5 mg/.5mL injection, solution, listed with the FDA by Alnylam Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxlumo (Lumasiran).
- What is the active ingredient?
- Lumasiran sodium.
- Who is the labeler?
- Alnylam Pharmaceuticals, Inc., NDC labeler code 71336. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxlumo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.