Prescription drug · ANDA
Tadalafil NDC 70518-3434
Tadalafil 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3434-0 | 70518343400 | 100 POUCH in 1 BOX (70518-3434-0) / 1 TABLET in 1 POUCH (70518-3434-1)Marketed from Jun 9, 2022 | |
| 70518-3434-2 | 70518343402 | 250 POUCH in 1 BOX (70518-3434-2) / 1 TABLET in 1 POUCH (70518-3434-1)Marketed from Jun 23, 2022 | |
| 70518-3434-4 | 70518343404 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-3434-4)Marketed from Jan 3, 2023 |
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 209654
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-3434_562d2e56-3f78-4651-e063-6294a90a39bcSPL ID 562d2e56-3f78-4651-e063-6294a90a39bcSPL set ID 415bd983-86f3-4f38-917a-9805024f31cbRxCUI 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
N470518343400followed by a unit qualifier and the quantityPackage 70518-3434-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 209654
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 | TabletOral | Bryant Ranch Prepack | 71335-1823 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-114 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-077 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-079 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | direct rx | 72189-145 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1491 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4534 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-396 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8292 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-5641 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Proficient Rx LP | 71205-734 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Proficient Rx LP | 71205-735 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Proficient Rx LP | 71205-736 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2421 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1670 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-184 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2554 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-552 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3540 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-551 |
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