Prescription drug · ANDA
Tadalafil NDC 80425-0443
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0443-1 | 80425044301 | 7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1)Marketed from Oct 15, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 210420
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0443_248a470e-c977-fb5c-e063-6394a90abb66SPL ID 248a470e-c977-fb5c-e063-6394a90abb66SPL set ID 248a4705-1403-e94a-e063-6294a90a3544RxCUI 402019UNII 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
N480425044301followed by a unit qualifier and the quantityPackage 80425-0443-01. 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: 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 Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil Tab…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210420
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 | Qilu Pharmaceutical Co., Ltd. | 67184-0524 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0525 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0526 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0523 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-730 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-727 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-728 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-729 |