Prescription drug · ANDA
Tadalafil NDC 16714-076
Tadalafil 10 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-076-01 | 16714007601 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-076-01)Marketed from Feb 19, 2020 |
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
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208934
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-076_2b1383b3-acce-43df-9aad-2d92c439b80fSPL ID 2b1383b3-acce-43df-9aad-2d92c439b80fSPL set ID 594acc15-a5bc-43b5-9659-a864b2c46eeaRxCUI 402019, 403957, 484814, 757707UNII 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
N416714007601followed by a unit qualifier and the quantityPackage 16714-0076-01. 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 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 tablets are indicate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208934
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 | NorthStar RxLLC | 16714-075 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-074 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-077 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1884 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8047 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7390 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7391 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-541 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1255 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-542 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-543 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-544 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8157 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-011 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-009 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-010 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-012 |