Prescription drug · BLA
Praluent (alirocumab) NDC 0024-5901
Alirocumab 75 mg/mL · Injection, Solution · Subcutaneous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5901-00 | 00024590100 | 1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASSMarketed from Jul 24, 2015 | |
| 0024-5901-01 | 00024590101 | 1 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASSMarketed from Jul 24, 2015 |
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)
- Praluent
- Generic name (nonproprietary)
- alirocumab
- Active ingredients
- Alirocumab — 75 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125559
- Marketing start
- Listing expires
- Other FDA classes
- Monoclonal (Chemical structure)PCSK9 Inhibitors (Mechanism)
- Identifiers
- Product ID 0024-5901_fba901c3-f56a-4d92-9e68-d1eac9aed031SPL ID fba901c3-f56a-4d92-9e68-d1eac9aed031SPL set ID 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4RxCUI 1659156, 1659161, 1659165, 1659167, 1659177, 1659179, 1659182, 1659183UNII PP0SHH6V16
- Pharmacologic class
- PCSK9 Inhibitor
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
N400024590100followed by a unit qualifier and the quantityPackage 00024-5901-00. 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)
PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events . As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH). PRALUENT is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated: To reduce the risk of major adverse cardiovascular (CV) events (corona…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125559
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 |
|---|---|---|---|---|
| Praluentalirocumab | Alirocumab 150 mg/mL | Injection, SolutionSubcutaneous | Regeneron Pharmaceuticals, Inc. | 61755-021 |
| Praluentalirocumab | Alirocumab 75 mg/mL | Injection, SolutionSubcutaneous | Regeneron Pharmaceuticals, Inc. | 61755-020 |
| Praluentalirocumab | Alirocumab 150 mg/mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5902 |