Prescription drug · ANDA
Tadalafil NDC 16729-370
Tadalafil 5 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-370-10 | 16729037010 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-370-10)Marketed from Mar 27, 2019 | |
| 16729-370-16 | 16729037016 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-370-16)Marketed from Apr 27, 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209167
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-370_4f99c59f-9b38-f54a-e063-6294a90a60eeSPL ID 4f99c59f-9b38-f54a-e063-6294a90a60eeSPL set ID eedf3ad9-7d40-496d-b1a9-6200010c18e1RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0316729372107, 0316729369107, 0316729370103
- 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
N416729037010followed by a unit qualifier and the quantityPackage 16729-0370-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 209167
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, Film coatedOral | Bryant Ranch Prepack | 63629-8409 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-473 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-487 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8153 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-369 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-371 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-372 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5186 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5202 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-720 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1587 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6150 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1620 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-502 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2553 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-126 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-268 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-269 |