Prescription drug · ANDA
tadalafil NDC 72789-344
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-344-15 | 72789034415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-15)Marketed from Aug 7, 2023 | |
| 72789-344-90 | 72789034490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-90)Marketed from Oct 24, 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
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215556
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 72789-344_40bb5cc5-f384-9589-e063-6394a90a4516SPL ID 40bb5cc5-f384-9589-e063-6394a90a4516SPL set ID 5de70f00-00ac-4656-883e-d1e07d5f71d6RxCUI 402019UNII 742SXX0ICTUPC 0372789344904
- 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
N472789034415followed by a unit qualifier and the quantityPackage 72789-0344-15. 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215556
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 | PD-RX Pharmaceuticals, Inc. | 72789-324 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | VKT Pharma Private Limited | 71821-009 |
| tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | VKT Pharma Private Limited | 71821-006 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | VKT Pharma Private Limited | 71821-007 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | VKT Pharma Private Limited | 71821-008 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-430 |
| tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-460 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-461 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-462 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-463 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7315 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7314 |