Prescription drug · NDA
Remodulin (Treprostinil) NDC 66302-101
Treprostinil 20 mg/20mL · Injection, Solution · Intravenous, Subcutaneous · United Therapeutics Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66302-101-01 | 66302010101 | 1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIALMarketed from May 22, 2002 |
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)
- Remodulin
- Generic name (nonproprietary)
- treprostinil
- Active ingredients
- Treprostinil — 20 mg/20mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- United Therapeutics CorporationNDC labeler code 66302
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021272
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 66302-101_b6a60240-eed2-4929-bb92-b139e8200652SPL ID b6a60240-eed2-4929-bb92-b139e8200652SPL set ID 6c80bb38-e8db-4138-9f0d-dbbf9c673185RxCUI 349407, 349408, 349409, 349410, 352211, 352212, 352213, 352214, 2590175, 2590177, 2667748, 2667750, 2667752, 2667754, 2667756, 2667758UNII 059QF0KO0R, 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
N466302010101followed by a unit qualifier and the quantityPackage 66302-0101-01. 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)
Remodulin 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 Remodulin is indicated for th…
Excerpt only. Read the full label for complete information.
About NDC 66302-101
- What is NDC 66302-101?
- 66302-101 is the product NDC for Remodulin (treprostinil), Treprostinil 20 mg/20mL injection, solution, listed with the FDA by United Therapeutics Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Remodulin (Treprostinil).
- What is the active ingredient?
- Treprostinil.
- Who is the labeler?
- United Therapeutics Corporation, NDC labeler code 66302. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Remodulin?
- 4 other product NDCs are listed under this name. See all Remodulin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Remodulin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Remodulintreprostinil | Treprostinil 8 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-114 | 66302-0114-01 |
| Remodulintreprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-102 | 66302-0102-01 |
| Remodulintreprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-105 | 66302-0105-01 |
| Remodulintreprostinil | Treprostinil 200 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-110 | 66302-0110-01 |
Other NDCs under NDA 021272
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 |
|---|---|---|---|---|
| Remodulintreprostinil | Treprostinil 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-102 |
| Sterile Diluent for Remodulinwater | Water 1 mL/mL | Injection, SolutionIntravenous | United Therapeutics Corporation | 66302-150 |
| Remodulintreprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-105 |
| Remodulintreprostinil | Treprostinil 200 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-110 |
| Remodulintreprostinil | Treprostinil 8 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | United Therapeutics Corporation | 66302-114 |