Prescription drug · ANDA
Tadalafil NDC 35561-255
Tadalafil 5 mg/1 · Tablet, Film coated · Oral · Bostal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35561-255-10 | 35561025510 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-10)Marketed from Nov 29, 2019 | |
| 35561-255-13 | 35561025513 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-13)Marketed from Nov 29, 2019 |
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
- Generic name (nonproprietary)
- tadalafil
- Active ingredients
- Tadalafil — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bostal LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208824
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 35561-255_49fc9e85-3dc2-064f-e063-6294a90af582SPL ID 49fc9e85-3dc2-064f-e063-6294a90af582SPL set ID 78509a43-a907-4359-9022-f38c4f765880RxCUI 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
N435561025510followed by a unit qualifier and the quantityPackage 35561-0255-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors 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 tabl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208824
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.