Prescription drug · NDA
Tracleer (Bosentan) NDC 66215-232
Bosentan 32 mg/1 · Tablet, For suspension · Oral · Actelion Pharmaceuticals US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66215-232-56 | 6621502325666215023256 | 4 BLISTER PACK in 1 CARTON (66215-232-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-232-14)Marketed from Jul 29, 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)
- Tracleer
- Generic name (nonproprietary)
- bosentan
- Active ingredients
- Bosentan — 32 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Actelion Pharmaceuticals US, Inc.NDC labeler code 66215
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209279
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 66215-232_f52a8c9c-529d-4bd8-9bfb-d91161935c20SPL ID f52a8c9c-529d-4bd8-9bfb-d91161935c20SPL set ID 749e42fb-2fe0-45dd-9268-b43bb3f4081cRxCUI 349253, 352066, 656659, 656660, 1989081, 1989085UNII Q326023R30
- Pharmacologic class
- Endothelin Receptor Antagonist
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466215023256followed by a unit qualifier and the quantityPackage 66215-0232-56. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1) ] . in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. TRACLEE…
Excerpt only. Read the full label for complete information.
About NDC 66215-232
- What is NDC 66215-232?
- 66215-232 is the product NDC for Tracleer (bosentan), Bosentan 32 mg/1 tablet, for suspension, listed with the FDA by Actelion Pharmaceuticals US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tracleer (Bosentan).
- What is the active ingredient?
- Bosentan.
- Who is the labeler?
- Actelion Pharmaceuticals US, Inc., NDC labeler code 66215. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tracleer?
- 2 other product NDCs are listed under this name. See all Tracleer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tracleer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tracleerbosentan | Bosentan 62.5 mg/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-101 | 66215-0101-0366215-0101-06 |
| Tracleerbosentan | Bosentan 125 mg/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-102 | 66215-0102-0366215-0102-06 |