Prescription drug · ANDA
Tadalafil NDC 68788-4018
Tadalafil 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4018-1 | 68788401801 | 15 TABLET in 1 BOTTLE (68788-4018-1)Marketed from Aug 29, 2025 | |
| 68788-4018-2 | 68788401802 | 20 TABLET in 1 BOTTLE (68788-4018-2)Marketed from Aug 29, 2025 | |
| 68788-4018-3 | 68788401803 | 30 TABLET in 1 BOTTLE (68788-4018-3)Marketed from Aug 29, 2025 |
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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211839
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-4018_f9e9a953-2802-4bb1-91a3-a29be347801eSPL ID f9e9a953-2802-4bb1-91a3-a29be347801eSPL set ID f9e9a953-2802-4bb1-91a3-a29be347801eRxCUI 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
N468788401801followed by a unit qualifier and the quantityPackage 68788-4018-01. 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 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.
About NDC 68788-4018
- What is NDC 68788-4018?
- 68788-4018 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tadalafil.
- What is the active ingredient?
- Tadalafil.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tadalafil?
- 242 other product NDCs are listed under this name. See all Tadalafil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tadalafil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-781 | 72603-0781-01 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-782 | 72603-0782-01 |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-783 | 72603-0783-01 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | NorthStar Rx, LLC | 72603-784 | 72603-0784-01 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4605 | 70518-4605-00 |
| tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4083 | 68788-4083-0168788-4083-0368788-4083-07 |
| Tadalafil | Tadalafil 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8039 | 50090-8039-0050090-8039-0150090-8039-02 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-027 | 60290-0027-0160290-0027-0260290-0027-03+1 more |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-028 | 60290-0028-0160290-0028-0260290-0028-03+1 more |
| Tadalafil | Tadalafil 10 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-029 | 60290-0029-0160290-0029-0260290-0029-03+1 more |
Other NDCs under ANDA 211839
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 | Torrent Pharmaceuticals Limited | 13668-565 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-566 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-567 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-568 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4605 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-546 |