Prescription drug · ANDA
Tadalafil NDC 50090-4660
Tadalafil 5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4660-0 | 50090466000 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-4660-0)Marketed from Oct 29, 2019 | |
| 50090-4660-1 | 50090466001 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4660-1)Marketed from Dec 10, 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209908
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-4660_646cb491-dc6a-462f-a6a2-a6e44ab519abSPL ID 646cb491-dc6a-462f-a6a2-a6e44ab519abSPL set ID c1c8feb4-a85a-4f39-8c44-bc9cd77226f4RxCUI 403957UNII 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
N450090466000followed by a unit qualifier and the quantityPackage 50090-4660-00. 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 tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablet is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablet is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablet is in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209908
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 | Camber Pharmaceuticals, Inc. | 31722-645 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-643 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-644 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-646 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6945 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceutical,Inc. | 68071-3929 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-106 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-104 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3936 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-107 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-108 |