Prescription drug · ANDA
Sterile Diluent for Treprostinil (water) NDC 43598-126
Water 1 mL/mL · Injection, Solution · Intravenous · Dr.Reddy's Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-126-11 | 43598012611 | 1 VIAL in 1 CARTON (43598-126-11) / 50 mL in 1 VIALMarketed from Feb 13, 2023 |
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)
- Sterile Diluent for Treprostinil
- Generic name (nonproprietary)
- water
- Active ingredients
- Water — 1 mL/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210214
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-126_61347918-bb33-236c-6a2e-280b59e7ab31SPL ID 61347918-bb33-236c-6a2e-280b59e7ab31SPL set ID 33050ee2-519b-1f0b-d4df-9e14dd329c57RxCUI 349407, 349408, 349409, 349410UNII RUM6K67ESG, 059QF0KO0RUPC 0343598126111
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
N443598012611followed by a unit qualifier and the quantityPackage 43598-0126-11. 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 vasodilator 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210214
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 50 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-646 |
| Treprostinil | Treprostinil 100 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-647 |
| Treprostinil | Treprostinil 200 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-648 |
| Treprostinil | Treprostinil 20 mg/20mL | Injection, SolutionIntravenous, Subcutaneous | Dr.Reddy's Laboratories Inc., | 43598-649 |