Prescription drug · ANDA
Dutasteride NDC 63629-8207
Dutasteride .5 mg/1 · Capsule, Liquid filled · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8207-1 | 63629820701 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1)Marketed from Aug 1, 2019 | |
| 63629-8207-2 | 63629820702 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2)Marketed from Jul 22, 2020 | |
| 63629-8207-3 | 63629820703 | 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)Marketed from Apr 11, 2022 | |
| 63629-8207-4 | 63629820704 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-4)Marketed from Apr 11, 2022 |
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)
- Dutasteride
- Generic name (nonproprietary)
- dutasteride
- Active ingredients
- Dutasteride — .5 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-8207_39450dfb-5076-4375-9bf6-c588eff58e9cSPL ID 39450dfb-5076-4375-9bf6-c588eff58e9cSPL set ID 170f01fe-5048-413c-b4cd-8311e1a2728aRxCUI 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
N463629820701followed by a unit qualifier and the quantityPackage 63629-8207-01. 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)
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 prostate to:…
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 | Proficient Rx LP | 71205-278 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 72162-1296 |