Prescription drug · ANDA
Tadalafil NDC 69238-1346
Tadalafil 2.5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1346-3 | 69238134603 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-1346-3)Marketed from Mar 27, 2019 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209744
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 69238-1346_5c6a682e-8bbe-4e9c-914c-148a5a0cb2a4SPL ID 5c6a682e-8bbe-4e9c-914c-148a5a0cb2a4SPL set ID 90f38460-62ad-492e-a3da-403d5a5a5d86RxCUI 402019, 403957, 484814, 757707UNII 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
N469238134603followed by a unit qualifier and the quantityPackage 69238-1346-03. 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 is 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 tablets are indicated f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209744
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 | AvKARE | 42291-867 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-864 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-865 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-866 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-567 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1349 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1347 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1348 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-581 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1346 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1347 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1348 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1349 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-603 |