Prescription drug · ANDA
Tadalafil NDC 50090-8039
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-8039-0 | 50090803900 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-8039-0)Marketed from Aug 26, 2026 | |
| 50090-8039-1 | 50090803901 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-8039-1)Marketed from Aug 26, 2026 | |
| 50090-8039-2 | 50090803902 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-8039-2)Marketed from Aug 26, 2026 |
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 — 20 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 211298
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-8039_477a0c36-bd80-40e9-adb2-456ee245063aSPL ID 477a0c36-bd80-40e9-adb2-456ee245063aSPL set ID cf9431ef-ea02-457d-b83a-ce13fb963d95RxCUI 402019UNII 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
N450090803900followed by a unit qualifier and the quantityPackage 50090-8039-00. 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 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 table…
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 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-407 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-408 |
| 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 |