Prescription drug · ANDA
Silodosin NDC 59651-095
Silodosin 4 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-095-30 | 5965100953059651009530 | 30 CAPSULE in 1 BOTTLE (59651-095-30)Marketed from Dec 10, 2018 | |
| 59651-095-90 | 5965100959059651009590 | 90 CAPSULE in 1 BOTTLE (59651-095-90)Marketed from Dec 10, 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
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210626
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 59651-095_ba067fa8-8f09-40fb-be9d-a9ff2b0fd72dSPL ID ba067fa8-8f09-40fb-be9d-a9ff2b0fd72dSPL set ID 5e5038ea-9214-469b-8174-e5787be7a801RxCUI 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
N459651009530followed by a unit qualifier and the quantityPackage 59651-0095-30. 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, 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.
About NDC 59651-095
- What is NDC 59651-095?
- 59651-095 is the product NDC for Silodosin, Silodosin 4 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Silodosin.
- What is the active ingredient?
- Silodosin.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Silodosin?
- 28 other product NDCs are listed under this name. See all Silodosin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Silodosin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2446 | 72162-2446-03 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2447 | 72162-2447-0372162-2447-09 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-113 | 82619-0113-01 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-114 | 82619-0114-0182619-0114-02 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | AvKARE | 42291-777 | 42291-0777-30 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | AvKARE | 42291-778 | 42291-0778-90 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-635 | 31722-0635-3031722-0635-3131722-0635-90+1 more |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-636 | 31722-0636-3031722-0636-3131722-0636-90+1 more |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-405 | 46708-0405-3046708-0405-9046708-0405-91 |
| Silodosin | Silodosin 8 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-406 | 46708-0406-3046708-0406-9046708-0406-91 |
Other NDCs under ANDA 210626
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 | Aurobindo Pharma Limited | 59651-096 |
| Silodosin | Silodosin 4 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-351 |