Prescription drug · ANDA
Tadalafil NDC 43598-574
Tadalafil 10 mg/1 · Tablet, Film coated · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-574-30 | 4359805743043598057430 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-574-30)Marketed from Mar 26, 2019 | |
| 43598-574-31 | 4359805743143598057431 | 3 BLISTER PACK in 1 CARTON (43598-574-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-574-79)Marketed from Apr 7, 2020 |
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, Film coated
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories IncNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210069
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-574_7d8af9db-e459-1195-41b8-67f96e390ef2SPL ID 7d8af9db-e459-1195-41b8-67f96e390ef2SPL set ID 22b8a2e3-d1b8-f193-45fa-77cc62a1b941RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0343598573304, 0343598574301, 0343598576305, 0343598575308
- 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
N443598057430followed by a unit qualifier and the quantityPackage 43598-0574-30. 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 ind…
Excerpt only. Read the full label for complete information.
About NDC 43598-574
- What is NDC 43598-574?
- 43598-574 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Dr.Reddys Laboratories Inc. It has 2 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?
- Dr.Reddys Laboratories Inc, NDC labeler code 43598. 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 210069
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 | Dr.Reddys Laboratories Inc | 43598-573 |
| Tadalafil | Tadalafil 5 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-575 |
| Tadalafil | Tadalafil 2.5 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-576 |