Prescription drug · ANDA
Tadalafil NDC 72865-104
Tadalafil 2.5 mg/1 · Tablet, Film coated · Oral · XLCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-104-30 | 72865010430 | 30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30)Marketed from Dec 10, 2024 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209908
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 72865-104_28d63724-c672-207c-e063-6294a90af28dSPL ID 28d63724-c672-207c-e063-6294a90af28dSPL set ID add6afb8-d38c-47a2-8c35-d5940667bb0cRxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0372865106303, 0372865104309, 0372865108307, 0372865107300
- 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
N472865010430followed by a unit qualifier and the quantityPackage 72865-0104-30. 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 is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablet is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablet is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablet is in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209908
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 |
|---|---|---|---|---|
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4660 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-106 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceutical,Inc. | 68071-3929 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-107 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-108 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3936 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-644 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-643 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-645 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-646 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6945 |