Prescription drug · ANDA
Silodosin NDC 69238-1421
Silodosin 4 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1421-3 | 69238142103 | 30 CAPSULE in 1 BOTTLE (69238-1421-3)Marketed from Dec 3, 2018 | |
| 69238-1421-9 | 69238142109 | 90 CAPSULE in 1 BOTTLE (69238-1421-9)Marketed from Dec 3, 2018 |
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)
- Silodosin
- Generic name (nonproprietary)
- silodosin
- Active ingredients
- Silodosin — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209745
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 69238-1421_36fb79b1-8d84-4afa-b26c-78a83394140dSPL ID 36fb79b1-8d84-4afa-b26c-78a83394140dSPL set ID de619e27-9384-4b86-abdc-de0557cd39e8RxCUI 809477, 826612UNII CUZ39LUY82
- Pharmacologic class
- alpha-Adrenergic Blocker
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
N469238142103followed by a unit qualifier and the quantityPackage 69238-1421-03. 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)
Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14 ) ] . Silodosin capsules are not indicated for the treatment of hypertension. Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209745
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 |
|---|---|---|---|---|
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1420 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1421 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1420 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | AvKARE | 42291-777 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | AvKARE | 42291-778 |