Prescription drug · ANDA
Silodosin NDC 31722-635
Silodosin 4 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-635-30 | 31722063530 | 30 CAPSULE in 1 BOTTLE (31722-635-30)Marketed from Feb 14, 2020 | |
| 31722-635-31 | 31722063531 | 30 CAPSULE in 1 BOTTLE (31722-635-31)Marketed from Feb 14, 2020 | |
| 31722-635-90 | 31722063590 | 90 CAPSULE in 1 BOTTLE (31722-635-90)Marketed from Feb 14, 2020 | |
| 31722-635-91 | 31722063591 | 90 CAPSULE in 1 BOTTLE (31722-635-91)Marketed from Feb 14, 2020 |
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)
- Silodosin
- Generic name (nonproprietary)
- silodosin
- Active ingredients
- Silodosin — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204793
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 31722-635_1a1f75e4-0d3a-55a0-e063-6294a90af183SPL ID 1a1f75e4-0d3a-55a0-e063-6294a90af183SPL set ID b9880aad-5fbe-470b-a7a0-d963ba4bc98bRxCUI 809477, 826612UNII CUZ39LUY82UPC 0331722636308, 0331722635905, 0331722636902, 0331722635301
- 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
N431722063530followed by a unit qualifier and the quantityPackage 31722-0635-30. 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)
Silodosin capsules, 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 capsules, 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 204793
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 | Camber Pharmaceuticals, Inc. | 31722-636 |