Prescription drug · ANDA
Silodosin NDC 68180-740
Silodosin 4 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-740-06 | 68180074006 | 30 CAPSULE in 1 BOTTLE (68180-740-06)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 — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206541
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 68180-740_9a808ee1-339e-42a3-b55c-b655c9d1fcb8SPL ID 9a808ee1-339e-42a3-b55c-b655c9d1fcb8SPL set ID 2300db48-477f-4357-8de9-f723737071b4RxCUI 809477, 826612UNII CUZ39LUY82UPC 0368180741091, 0368180740063
- 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
N468180074006followed by a unit qualifier and the quantityPackage 68180-0740-06. 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, 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 ) 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206541
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 | Lupin Pharmaceuticals, Inc. | 68180-741 |