Prescription drug · ANDA
Tadalafil NDC 72789-408
Tadalafil 10 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-408-30 | 72789040830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-408-30)Marketed from Jun 11, 2024 | |
| 72789-408-90 | 72789040890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-408-90)Marketed from Jun 11, 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 — 10 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 211298
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 72789-408_3246ff9a-b8c3-454f-e063-6294a90abcb2SPL ID 3246ff9a-b8c3-454f-e063-6294a90abcb2SPL set ID 828f0ee1-b9fc-4743-9394-fc086bcf5345RxCUI 484814UNII 742SXX0ICTUPC 0372789408309
- 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
N472789040830followed by a unit qualifier and the quantityPackage 72789-0408-30. 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 tablet 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 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211298
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 | Umedica Laboratories USA Inc. | 60290-030 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-029 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-782 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-781 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-783 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-784 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-028 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-027 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-248 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-247 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-249 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-250 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8039 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-407 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-040 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-041 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-042 |