Prescription drug · ANDA
Treprostinil NDC 62332-514
Treprostinil 20 mg/20mL · Injection, Solution · Intravenous, Subcutaneous · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-514-20 | 62332051420 | 1 VIAL in 1 CARTON (62332-514-20) / 20 mL in 1 VIALMarketed from Feb 11, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Treprostinil
- Generic name (nonproprietary)
- treprostinil
- Active ingredients
- Treprostinil — 20 mg/20mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211574
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 62332-514_5384ef7c-88cc-4ab7-8eb7-627eba752f9dSPL ID 5384ef7c-88cc-4ab7-8eb7-627eba752f9dSPL set ID 4a684b13-669d-4721-8ed4-30cc7762b0b8RxCUI 349407, 349408, 349409, 349410UNII RUM6K67ESG
- Pharmacologic class
- Prostacycline Vasodilator
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
N462332051420followed by a unit qualifier and the quantityPackage 62332-0514-20. 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)
Treprostinil injection is a prostacyclin mimetic indicated for: • Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1) • Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2) 1.1 Pulmonary Arterial Hypertension Treprostinil inj…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211574
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 |
|---|---|---|---|---|
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-516 |
| Treprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-515 |
| Treprostinil | Treprostinil 200 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-517 |