Prescription drug · ANDA
Dutasteride NDC 71205-278
Dutasteride .5 mg/1 · Capsule, Liquid filled · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-278-30 | 71205027830 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-30)Marketed from May 1, 2019 | |
| 71205-278-60 | 71205027860 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-60)Marketed from May 1, 2019 | |
| 71205-278-90 | 71205027890 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-90)Marketed from May 1, 2019 |
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)
- Dutasteride
- Generic name (nonproprietary)
- dutasteride
- Active ingredients
- Dutasteride — .5 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206574
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-278_85ae04d1-a76d-49b9-bb46-8dd37e7881a1SPL ID 85ae04d1-a76d-49b9-bb46-8dd37e7881a1SPL set ID 908832b2-21d6-48ae-89cb-f06687321f74RxCUI 351172UNII O0J6XJN02I
- Pharmacologic class
- 5-alpha Reductase 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
N471205027830followed by a unit qualifier and the quantityPackage 71205-0278-30. 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)
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) • improve symptoms, • reduce the risk of acute urinary retention, and • reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. ( 1.3 ) 1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206574
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 |
|---|---|---|---|---|
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Camber Pharmaceuticals, Inc. | 31722-131 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-1222 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-1223 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | XLCare Pharmaceuticals, Inc. | 72865-140 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals,Inc. | 68071-4821 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals, Inc. | 68071-3732 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-4010 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-8207 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 72162-1296 |