Prescription drug · NDA
Givlaari (givosiran sodium) NDC 71336-1001
Givosiran sodium 189 mg/mL · Injection, Solution · Subcutaneous · Alnylam Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71336-1001-1 | 71336100101 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Dec 12, 2019 |
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)
- Givlaari
- Generic name (nonproprietary)
- givosiran sodium
- Active ingredients
- Givosiran sodium — 189 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212194
- Marketing start
- Listing expires
- Other FDA classes
- Decreased RNA Integrity (Physiologic effect)Small Interfering (Chemical structure)
- Identifiers
- Product ID 71336-1001_942492a0-de6e-4c31-8b9c-d259f808d821SPL ID 942492a0-de6e-4c31-8b9c-d259f808d821SPL set ID 167e663c-11e1-497b-a3fc-951d65d58eaaRxCUI 2265716, 2265721UNII 5XE21E41RT
- Pharmacologic class
- Aminolevulinate Synthase 1-directed RNA Interaction; Small Interfering RNA
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
N471336100101followed by a unit qualifier and the quantityPackage 71336-1001-01. 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)
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP). ( 1 )
Excerpt only. Read the full label for complete information.