Prescription drug · ANDA
Tadalafil NDC 72303-0822
Tadalafil 2.5 mg/1 · Tablet, Film coated · Oral · HEC Pharm USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72303-0822-1 | 72303082201 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72303-0822-1)Marketed from Mar 27, 2019 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- HEC Pharm USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211335
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 72303-0822_4c53221b-7a21-9531-e063-6294a90a9ac4SPL ID 4c53221b-7a21-9531-e063-6294a90a9ac4SPL set ID a0f728b6-2cc6-cb65-e053-2a95a90ab142RxCUI 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
N472303082201followed by a unit qualifier and the quantityPackage 72303-0822-01. 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, USP are 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, USP 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, USP are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperpl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211335
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 20 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0825 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0823 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0824 |
- openFDA data updated
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