Prescription drug · ANDA
Tadalafil NDC 76420-552
Tadalafil 2.5 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-552-05 | 76420055205 | 500 TABLET in 1 BOTTLE (76420-552-05)Marketed from Mar 28, 2023 | |
| 76420-552-12 | 76420055212 | 120 TABLET in 1 BOTTLE (76420-552-12)Marketed from Mar 28, 2023 | |
| 76420-552-30 | 76420055230 | 30 TABLET in 1 BOTTLE (76420-552-30)Marketed from Mar 28, 2023 | |
| 76420-552-60 | 76420055260 | 60 TABLET in 1 BOTTLE (76420-552-60)Marketed from Mar 28, 2023 | |
| 76420-552-90 | 76420055290 | 90 TABLET in 1 BOTTLE (76420-552-90)Marketed from Mar 28, 2023 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, 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 76420-552_f7f0bf23-1272-256a-e053-6294a90a40eeSPL ID f7f0bf23-1272-256a-e053-6294a90a40eeSPL set ID 5ea24573-2d16-40d8-a46c-7b5fa8669e69RxCUI 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
N476420055205followed by a unit qualifier and the quantityPackage 76420-0552-05. 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 is 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 indicated…
Excerpt only. Read the full label for complete information.
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 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3434 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-3540 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-551 |
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