Prescription drug · ANDA
Alfuzosin hydrochloride NDC 29300-155
Alfuzosin hydrochloride 10 mg/1 · Tablet, Extended release · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-155-01 | 29300015501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-01)Marketed from Mar 15, 2016 | |
| 29300-155-13 | 29300015513 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-13)Marketed from Mar 15, 2016 | |
| 29300-155-19 | 29300015519 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-19)Marketed from Mar 15, 2016 |
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)
- Alfuzosin hydrochloride
- Generic name (nonproprietary)
- alfuzosin hydrochloride
- Active ingredients
- Alfuzosin hydrochloride — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203192
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 29300-155_8190595a-be8e-4fd0-bcdf-30b6ba64ef5aSPL ID 8190595a-be8e-4fd0-bcdf-30b6ba64ef5aSPL set ID 644295a9-75cb-4326-a71f-b0f4e0c4cf75RxCUI 861132UNII 75046A1XTN
- 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
N429300015501followed by a unit qualifier and the quantityPackage 29300-0155-01. 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)
Alfuzosin hydrochloride extended-release tablets, USP, an alpha adrenergic antagonist, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets, USP are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population. ( 1.1 , 8.4 , 12.3 ) Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203192
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 |
|---|---|---|---|---|
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-967 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-9155 |