Prescription drug · ANDA
Tadalafil NDC 24979-730
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24979-730-06 | 24979073006 | 30 TABLET, FILM COATED in 1 BOTTLE (24979-730-06)Marketed from Apr 7, 2024 | |
| 24979-730-44 | 24979073044 | 120 TABLET, FILM COATED in 1 BOTTLE (24979-730-44)Marketed from Apr 7, 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 — 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 24979-730_555edf7e-85bf-492f-8e14-c53f72aa5b38SPL ID 555edf7e-85bf-492f-8e14-c53f72aa5b38SPL set ID ae801b15-0462-44af-99a4-affe3eed899aRxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0324979727028, 0324979728025, 0324979730448, 0324979730066, 0324979729695, 0324979729060
- 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
N424979073006followed by a unit qualifier and the quantityPackage 24979-0730-06. 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 20 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0443 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-729 |
| 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 | Qilu Pharmaceutical Co., Ltd. | 67184-0525 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0523 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0524 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0526 |