Prescription drug · ANDA
Tadalafil NDC 43547-033
Tadalafil 20 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-033-03 | 43547003303 | 30 TABLET in 1 BOTTLE (43547-033-03)Marketed from Nov 27, 2024 | |
| 43547-033-50 | 43547003350 | 500 TABLET in 1 BOTTLE (43547-033-50)Marketed from Nov 27, 2024 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210609
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-033_bdb087ff-a428-434e-b23b-0437f8672219SPL ID bdb087ff-a428-434e-b23b-0437f8672219SPL set ID 491cb72b-71f2-4df9-99f8-c02d93500103RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0343547030032, 0343547032036, 0343547033033, 0343547031039
- 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
N443547003303followed by a unit qualifier and the quantityPackage 43547-0033-03. 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 Tadalaf…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210609
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 | NuCare Pharmaceuticals,Inc.. | 68071-3598 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2626 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3601 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2363 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3864 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7152 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-032 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-030 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-031 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-050 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-047 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-049 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-051 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-903 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-908 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-909 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8664 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3753 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3758 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3781 |
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