Prescription drug · ANDA
Treprostinil NDC 62332-517
Treprostinil 200 mg/20mL · Injection, Solution · Intravenous, Subcutaneous · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-517-20 | 62332051720 | 1 VIAL in 1 CARTON (62332-517-20) / 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 — 200 mg/20mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- 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 62332-517_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
N462332051720followed by a unit qualifier and the quantityPackage 62332-0517-20. 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.
About NDC 62332-517
- What is NDC 62332-517?
- 62332-517 is the product NDC for Treprostinil, Treprostinil 200 mg/20mL injection, solution, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Treprostinil.
- What is the active ingredient?
- Treprostinil.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Treprostinil?
- 15 other product NDCs are listed under this name. See all Treprostinil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Treprostinil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Treprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-646 | 43598-0646-11 |
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-647 | 43598-0647-11 |
| Treprostinil | Treprostinil 200 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-648 | 43598-0648-11 |
| Treprostinil | Treprostinil 20 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-649 | 43598-0649-11 |
| Treprostinil | Treprostinil 20 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-514 | 62332-0514-20 |
| Treprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-515 | 62332-0515-20 |
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-516 | 62332-0516-20 |
| Treprostinil | Treprostinil 20 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Teva Parenteral Medicines, Inc. | 0703-0666 | 00703-0666-01 |
| Treprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Teva Parenteral Medicines, Inc. | 0703-0676 | 00703-0676-01 |
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Teva Parenteral Medicines, Inc. | 0703-0686 | 00703-0686-01 |
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 20 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-514 |
| Treprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-515 |
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-516 |