Prescription drug · ANDA
tadalafil NDC 67296-2237
Tadalafil 10 mg/1 · Tablet, Film coated · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2237-2 | 67296223702 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67296-2237-2)Marketed from Mar 26, 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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Redpharm Drug
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209250
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 67296-2237_52505a7a-e3de-7c4e-e063-6294a90a1473SPL ID 52505a7a-e3de-7c4e-e063-6294a90a1473SPL set ID 52505a7a-e3dd-7c4e-e063-6294a90a1473RxCUI 484814UNII 742SXX0ICTUPC 0329300286823
- 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
N467296223702followed by a unit qualifier and the quantityPackage 67296-2237-02. 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 Tablets are 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 209250
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 | Proficient Rx LP | 82804-112 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3175 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2467 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-288 |
| tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-286 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-287 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-289 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-224 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4083 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-754 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3777 |
| tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-854 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-855 |
| tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-856 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-857 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2583 |
| tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3586 |