Prescription drug · ANDA
Tadalafil NDC 51655-473
Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-473-54 | 51655047354 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-473-54)Marketed from Nov 6, 2020 | |
| 51655-473-87 | 51655047387 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-473-87)Marketed from Nov 6, 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 51655-473_490f1639-8284-d34e-e063-6394a90aa16eSPL ID 490f1639-8284-d34e-e063-6394a90aa16eSPL set ID f3092f5a-b976-91ab-e053-2995a90a9b50RxCUI 402019UNII 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
N451655047354followed by a unit qualifier and the quantityPackage 51655-0473-54. 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 …
Excerpt only. Read the full label for complete information.
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 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 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-370 |
| 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 |
- openFDA data updated
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