Prescription drug · ANDA
Tadalafil NDC 63629-8409
Tadalafil 2.5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8409-1 | 63629840901 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8409-1)Marketed from Jan 7, 2021 | |
| 63629-8409-2 | 63629840902 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8409-2)Marketed from Jun 14, 2022 | |
| 63629-8409-3 | 63629840903 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-8409-3)Marketed from Oct 29, 2024 | |
| 63629-8409-4 | 63629840904 | 20 TABLET, FILM COATED in 1 BOTTLE (63629-8409-4)Marketed from Oct 29, 2024 | |
| 63629-8409-5 | 63629840905 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-8409-5)Marketed from Oct 29, 2024 |
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
- Bryant Ranch Prepack
- 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 63629-8409_65ab8b40-b3c9-4cae-9c6f-e96ac318837dSPL ID 65ab8b40-b3c9-4cae-9c6f-e96ac318837dSPL set ID 07567ae5-7345-4ab1-9b2c-c586c4da0427RxCUI 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
N463629840901followed by a unit qualifier and the quantityPackage 63629-8409-01. 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 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 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 |