Prescription drug · ANDA
tadalafil NDC 35573-463
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-463-30 | 35573046330 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-463-30)Marketed from Apr 1, 2023 |
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
- Burel Pharmaceuticals, LLC
- 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 35573-463_da1eee2b-ebe6-4af3-ad52-2b349a360a9aSPL ID da1eee2b-ebe6-4af3-ad52-2b349a360a9aSPL set ID a2e7f393-5cfc-45e5-b87d-9e8abc8e4355RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0335573463304, 0335573462307
- 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
N435573046330followed by a unit qualifier and the quantityPackage 35573-0463-30. 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 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 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-430 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-461 |
| tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-460 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-462 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7314 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7315 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | VKT Pharma Private Limited | 71821-009 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | PD-RX Pharmaceuticals, Inc. | 72789-324 |
| 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 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-344 |