Prescription drug · ANDA
Tadalafil NDC 70771-1475
Tadalafil 2.5 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1475-0 | 70771147500 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1475-0)Marketed from Mar 27, 2019 | |
| 70771-1475-1 | 70771147501 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1475-1)Marketed from Mar 27, 2019 | |
| 70771-1475-3 | 70771147503 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1475-3)Marketed from Mar 27, 2019 | |
| 70771-1475-4 | 70771147504 | 2 BLISTER PACK in 1 CARTON (70771-1475-4) / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 27, 2019 | |
| 70771-1475-5 | 70771147505 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1475-5)Marketed from Mar 27, 2019 | |
| 70771-1475-9 | 70771147509 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1475-9)Marketed from Mar 27, 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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206693
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1475_89266030-a1a1-4825-b9f0-9400886b6282SPL ID 89266030-a1a1-4825-b9f0-9400886b6282SPL set ID 6c1c3a1f-80a4-417c-8830-5edbb9a0710fRxCUI 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
N470771147500followed by a unit qualifier and the quantityPackage 70771-1475-00. 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 .
Other NDCs under ANDA 206693
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 | Northwind Health Company, LLC | 51655-063 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-899 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-896 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-897 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-898 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1476 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1477 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1478 |