Prescription drug · ANDA
Tadalafil NDC 72189-145
Tadalafil 5 mg/1 · Tablet · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-145-30 | 7218901453072189014530 | 30 TABLET in 1 BOTTLE (72189-145-30)Marketed from Nov 12, 2020 | |
| 72189-145-90 | 7218901459072189014590 | 90 TABLET in 1 BOTTLE (72189-145-90)Marketed from Nov 12, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- direct rxNDC labeler code 72189
- 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 72189-145_397f5fde-810b-642f-e063-6294a90ae47bSPL ID 397f5fde-810b-642f-e063-6294a90ae47bSPL set ID b3ee8325-bcb2-43fd-e053-2a95a90a08c8RxCUI 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
N472189014530followed by a unit qualifier and the quantityPackage 72189-0145-30. 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)
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 Hyperplasia Tadalafil tablets, USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is …
Excerpt only. Read the full label for complete information.
About NDC 72189-145
- What is NDC 72189-145?
- 72189-145 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by direct rx. 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?
- direct rx, NDC labeler code 72189. 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 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 | Ajanta Pharma USA Inc. | 27241-111 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-112 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-113 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-114 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-5641 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8288 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2421 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2554 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2632 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3540 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8292 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8445 |
| Tadalafil | Tadalafil 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3434 |
| Tadalafil | Tadalafil 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4534 |
| 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 | Bryant Ranch Prepack | 71335-1491 |
| Tadalafil | Tadalafil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1670 |
| Tadalafil | Tadalafil 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1823 |
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