Prescription drug · NDA
Onpattro (Patisiran) NDC 71336-1000
Patisiran sodium 2 mg/mL · Injection, Lipid complex · Intravenous · Alnylam Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71336-1000-1 | 71336100001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 13, 2018 |
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)
- Onpattro
- Generic name (nonproprietary)
- patisiran
- Active ingredients
- Patisiran sodium — 2 mg/mL
- Dosage form
- Injection, Lipid complex
- Route
- Intravenous
- Labeler
- Alnylam Pharmaceuticals, Inc.NDC labeler code 71336
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210922
- Marketing start
- Listing expires
- Other FDA classes
- Decreased RNA Integrity (Physiologic effect)Increased Protein Breakdown (Physiologic effect)Small Interfering (Chemical structure)
- Identifiers
- Product ID 71336-1000_254d330d-6f47-45c4-9774-95864ab46941SPL ID 254d330d-6f47-45c4-9774-95864ab46941SPL set ID e87ec36f-b4b4-49d4-aea4-d4ffb09b0970RxCUI 2053524, 2053529UNII WO0YM16LKG
- Pharmacologic class
- Small Interfering RNA; Transthyretin-directed RNA Interaction
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
N471336100001followed by a unit qualifier and the quantityPackage 71336-1000-01. 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)
ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ONPATTRO contains a transthyretin-directed small interfering RNA and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Excerpt only. Read the full label for complete information.
About NDC 71336-1000
- What is NDC 71336-1000?
- 71336-1000 is the product NDC for Onpattro (patisiran), Patisiran sodium 2 mg/mL injection, lipid complex, 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?
- Onpattro (Patisiran).
- What is the active ingredient?
- Patisiran 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 Onpattro?
- 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.