Prescription drug · ANDA
Tadalafil NDC 33342-278
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-278-07 | 33342027807 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07)Marketed from Oct 30, 2019 | |
| 33342-278-09 | 33342027809 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09)Marketed from Oct 30, 2019 |
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)
- Tadalafil
- Generic name (nonproprietary)
- tadalafil
- Active ingredients
- Tadalafil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207290
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-278_8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2SPL ID 8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2SPL set ID 93dd604f-8f38-4600-afe8-0fcc92fd2497RxCUI 2123194UNII 742SXX0ICT
- 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
N433342027807followed by a unit qualifier and the quantityPackage 33342-0278-07. 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)
Tadalafil tablets are 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 Tadalafil tablets are 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 …
Excerpt only. Read the full label for complete information.