Prescription drug · NDA
Adcirca (Tadalafil) NDC 66302-467
Tadalafil 20 mg/1 · Tablet · Oral · United Therapeutics Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66302-467-60 | 66302046760 | 60 TABLET in 1 BOTTLE (66302-467-60)Marketed from Aug 3, 2009 |
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)
- Adcirca
- Generic name (nonproprietary)
- tadalafil
- Active ingredients
- Tadalafil — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- United Therapeutics CorporationNDC labeler code 66302
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022332
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 66302-467_76c30323-0981-499c-b552-1a43f01c89c8SPL ID 76c30323-0981-499c-b552-1a43f01c89c8SPL set ID ff61b237-be8e-461b-8114-78c52a8ad0aeRxCUI 849866, 2123194UNII 742SXX0ICTUPC 0366302467607
- Pharmacologic class
- Phosphodiesterase 5 Inhibitor
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
N466302046760followed by a unit qualifier and the quantityPackage 66302-0467-60. 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)
ADCIRCA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension ADCIRCA ® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heri…
Excerpt only. Read the full label for complete information.
About NDC 66302-467
- What is NDC 66302-467?
- 66302-467 is the product NDC for Adcirca (tadalafil), Tadalafil 20 mg/1 tablet, 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?
- Adcirca (Tadalafil).
- What is the active ingredient?
- Tadalafil.
- 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 Adcirca?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.