Prescription drug · ANDA
Tadalafil NDC 70518-4605
Tadalafil 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4605-0 | 70518460500 | 50 POUCH in 1 BOX (70518-4605-0) / 1 TABLET in 1 POUCH (70518-4605-1)Marketed from Apr 22, 2026 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211839
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4605_50200848-abf9-c824-e063-6294a90a8190SPL ID 50200848-abf9-c824-e063-6294a90a8190SPL set ID 82dfea4c-9fe5-438a-917f-8f7d395ee8caRxCUI 403957UNII 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
N470518460500followed by a unit qualifier and the quantityPackage 70518-4605-00. 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 .
Indications (excerpt from the label)
Tadalafil tablets are 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 tab…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211839
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 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4018 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-565 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-566 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-567 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-568 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-546 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.