Prescription drug · NDA
Rivfloza (Nedosiran) NDC 0169-5308
Nedosiran sodium 80 mg/.5mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-5308-01 | 00169530801 | 1 VIAL in 1 CARTON (0169-5308-01) / .5 mL in 1 VIALMarketed from Feb 19, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Rivfloza
- Generic name (nonproprietary)
- nedosiran
- Active ingredients
- Nedosiran sodium — 80 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215842
- Marketing start
- Listing expires
- Identifiers
- Product ID 0169-5308_758d66fb-0447-4f26-905f-595b182aebdcSPL ID 758d66fb-0447-4f26-905f-595b182aebdcSPL set ID ace9d4bc-4d20-4beb-9e9d-888690424833RxCUI 2675303, 2675309, 2675312, 2675315, 2675317, 2675318UNII EGR9KYM536
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
N400169530801followed by a unit qualifier and the quantityPackage 00169-5308-01. 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)
RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 [see Clinical Pharmacology ( 12.3 )], Clinical Studies ( 14.1 )]. RIVFLOZA is an LDHA -directed small interfering RNA indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 . ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0169-5308
- What is NDC 0169-5308?
- 0169-5308 is the product NDC for Rivfloza (nedosiran), Nedosiran sodium 80 mg/.5mL injection, solution, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rivfloza (Nedosiran).
- What is the active ingredient?
- Nedosiran sodium.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rivfloza?
- 2 other product NDCs are listed under this name. See all Rivfloza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rivfloza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rivflozanedosiran | Nedosiran sodium 160 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-5306 | 00169-5306-10 |
| Rivflozanedosiran | Nedosiran sodium 128 mg/.8mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-5307 | 00169-5307-08 |
Other NDCs under NDA 215842
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 |
|---|---|---|---|---|
| Rivflozanedosiran | Nedosiran sodium 160 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-5306 |
| Rivflozanedosiran | Nedosiran sodium 128 mg/.8mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-5307 |