Prescription drug · ANDA
Tadalafil NDC 72789-184
Tadalafil 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-184-90 | 72789018490 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-184-90)Marketed from Aug 17, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, 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 72789-184_48330938-a426-2657-e063-6294a90aa2d9SPL ID 48330938-a426-2657-e063-6294a90aa2d9SPL set ID f34e4747-28be-4ae5-ac9a-a825083b6a9bRxCUI 484814UNII 742SXX0ICTUPC 0372789184906
- 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
N472789018490followed by a unit qualifier and the quantityPackage 72789-0184-90. 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 | 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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