Prescription drug · ANDA
Diluent (Water solution) NDC 0781-6021
Water 1 mL/mL · Injection · Intravenous, Subcutaneous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-6021-94 | 0078160219400781602194 | 1 VIAL in 1 CARTON (0781-6021-94) / 50 mL in 1 VIALMarketed from Mar 25, 2019 |
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)
- Diluent
- Generic name (nonproprietary)
- water solution
- Active ingredients
- Water — 1 mL/mL
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203649
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-6021_fe80d00e-9eba-4192-9515-f9a5ad686a53SPL ID fe80d00e-9eba-4192-9515-f9a5ad686a53SPL set ID 473297ca-a872-4052-a053-87dc8f0d3c13RxCUI 349407, 349408, 349409, 349410UNII 059QF0KO0R, RUM6K67ESG
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
N400781602194followed by a unit qualifier and the quantityPackage 00781-6021-94. 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…
Excerpt only. Read the full label for complete information.
About NDC 0781-6021
- What is NDC 0781-6021?
- 0781-6021 is the product NDC for Diluent (water solution), Water 1 mL/mL injection, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diluent (Water solution).
- What is the active ingredient?
- Water.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diluent?
- 1 other product NDC are listed under this name. See all Diluent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diluent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diluentsodium chloride | Sodium chloride 4.5 mg/.5mL | InjectionSubcutaneous | Sanofi Vaccines US Inc. | 49281-912 | 49281-0912-0549281-0912-10 |
Other NDCs under ANDA 203649
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 | InjectionIntravenous, Subcutaneous | Sandoz Inc | 0781-3420 |
| Treprostinil | Treprostinil 50 mg/20mL | InjectionIntravenous, Subcutaneous | Sandoz Inc | 0781-3425 |
| Treprostinil | Treprostinil 100 mg/20mL | InjectionIntravenous, Subcutaneous | Sandoz Inc | 0781-3427 |
| Treprostinil | Treprostinil 200 mg/20mL | InjectionIntravenous, Subcutaneous | Sandoz Inc | 0781-3430 |