Prescription drug · ANDA
Tadalafil NDC 62332-177
Tadalafil 2.5 mg/1 · Tablet, Coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-177-15 | 62332017715 | 30 TABLET, COATED in 1 CARTON (62332-177-15)Marketed from Mar 26, 2019 | |
| 62332-177-30 | 62332017730 | 30 TABLET, COATED in 1 BOTTLE (62332-177-30)Marketed from Dec 3, 2021 | |
| 62332-177-71 | 62332017771 | 500 TABLET, COATED in 1 BOTTLE (62332-177-71)Marketed from Aug 2, 2024 | |
| 62332-177-91 | 62332017791 | 1000 TABLET, COATED in 1 BOTTLE (62332-177-91)Marketed from Aug 2, 2024 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204809
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-177_76b22a5c-175e-433e-bd1e-5fefb0a78d5fSPL ID 76b22a5c-175e-433e-bd1e-5fefb0a78d5fSPL set ID abcb2cda-9b3f-45f6-ad5f-c2370b0dd114RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0362332180301, 0362332178308, 0362332177301, 0362332179305
- 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
N462332017715followed by a unit qualifier and the quantityPackage 62332-0177-15. 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 USP 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 USP 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 USP are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia T…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204809
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 2.5 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-177 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-178 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-179 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-180 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-178 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-179 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-180 |