What is NDC 0078-1000?

0078-1000 is the product NDC for Leqvio (inclisiran), Inclisiran sodium 284 mg/1.5mL injection, solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Leqvio?

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.

Leqvio NDC 0078-1000 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-1000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-1000Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0078-1000-60	00078100060	1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASSMarketed from Dec 22, 2021
0078-1000-98	00078100098	1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASSMarketed from Feb 17, 2023 · Sample package

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): Leqvio
Generic name (nonproprietary): inclisiran
Active ingredients: Inclisiran sodium — 284 mg/1.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214012
Marketing start: Dec 22, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 0078-1000_e4109fce-9d82-4800-8eae-fed97097241fSPL ID e4109fce-9d82-4800-8eae-fed97097241fSPL set ID 6fc0afca-4513-4c35-b594-6544aee29a44RxCUI 2588263, 2588269UNII UPC6BTX7PY

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.

How CPT relates to drug billing

NDC on a medical claim

N400078100060 followed by a unit qualifier and the quantity

Package 00078-1000-60. 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 Aug 19, 2026.

Indications (excerpt from the label)

LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LEQVIO is a small interfering RNA (siR…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-1000

What is NDC 0078-1000?: 0078-1000 is the product NDC for Leqvio (inclisiran), Inclisiran sodium 284 mg/1.5mL injection, solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leqvio (Inclisiran).
What is the active ingredient?: Inclisiran sodium.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leqvio?: 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.

Leqvio (Inclisiran) NDC 0078-1000