Prescription drug · ANDA
Silodosin NDC 72205-010
Silodosin 8 mg/1 · Capsule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-010-30 | 72205001030 | 30 CAPSULE in 1 BOTTLE (72205-010-30)Marketed from Dec 3, 2018 | |
| 72205-010-90 | 72205001090 | 90 CAPSULE in 1 BOTTLE (72205-010-90)Marketed from Dec 3, 2018 |
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 — 8 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210687
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 72205-010_43e34468-1d75-4953-92c8-fbaae64f7ce3SPL ID 43e34468-1d75-4953-92c8-fbaae64f7ce3SPL set ID ee8d577e-948d-4164-9671-c876544ac83bRxCUI 809477, 826612UNII CUZ39LUY82UPC 0372205010307, 0372205010901, 0372205009301
- 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
N472205001030followed by a unit qualifier and the quantityPackage 72205-0010-30. 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 capsule, 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 capsule is not indicated for the treatment of hypertension. Silodosin capsule, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210687
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.