Prescription drug · ANDA
Dutasteride NDC 50090-7852
Dutasteride .5 mg/1 · Capsule, Liquid filled · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7852-0 | 5009078520050090785200 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-0)Marketed from Jan 8, 2026 | |
| 50090-7852-1 | 5009078520150090785201 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-1)Marketed from Jan 8, 2026 |
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
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209909
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-7852_067a71d1-2d8f-4ca2-acb9-06718a5eb8c6SPL ID 067a71d1-2d8f-4ca2-acb9-06718a5eb8c6SPL set ID af338f55-55c1-4034-9c27-c3564addf24eRxCUI 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
N450090785200followed by a unit qualifier and the quantityPackage 50090-7852-00. 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 capsules 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 capsules 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 capsules 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 …
Excerpt only. Read the full label for complete information.
About NDC 50090-7852
- What is NDC 50090-7852?
- 50090-7852 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dutasteride.
- What is the active ingredient?
- Dutasteride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dutasteride?
- 20 other product NDCs are listed under this name. See all Dutasteride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dutasteride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dutasteride | Dutasteride .5 mg/1 | CapsuleOral | Banyan Pharma LLC | 84091-100 | 84091-0100-90 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-7305 | 50090-7305-0050090-7305-01 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Aurobindo Pharma Limited | 59651-021 | 59651-0021-3059651-0021-90 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | XLCare Pharmaceuticals, Inc. | 72865-140 | 72865-0140-3072865-0140-90 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Epic Pharma, LLC | 42806-549 | 42806-0549-0942806-0549-30 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals, Inc. | 68071-3757 | 68071-3757-06 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals, Inc. | 68071-3857 | 68071-3857-09 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-011 | 25000-0011-0325000-0011-0725000-0011-27 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-763 | 64380-0763-0464380-0763-05 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | Camber Pharmaceuticals, Inc. | 31722-131 | 31722-0131-3031722-0131-90 |
Other NDCs under ANDA 209909
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 | Epic Pharma, LLC | 42806-549 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals, Inc. | 68071-3757 |
| Dutasteride | Dutasteride .5 mg/1 | Capsule, Liquid filledOral | NuCare Pharmaceuticals, Inc. | 68071-3857 |