Prescription drug · ANDA
Dutasteride NDC 64380-763
Dutasteride .5 mg/1 · Capsule, Liquid filled · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-763-04 | 64380076304 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-04)Marketed from Dec 9, 2016 | |
| 64380-763-05 | 64380076305 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-05)Marketed from Dec 10, 2016 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204262
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 64380-763_5a02c220-eebe-ba1b-e063-6394a90af2bcSPL ID 5a02c220-eebe-ba1b-e063-6394a90af2bcSPL set ID c78d18cf-05df-4154-b2f9-39cc374ca9e3RxCUI 351172UNII O0J6XJN02IUPC 0364380763048, 0364380763055
- 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
N464380076304followed by a unit qualifier and the quantityPackage 64380-0763-04. 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 prosta…
Excerpt only. Read the full label for complete information.