Prescription drug · ANDA
Alfuzosin hydrochloride NDC 76282-302
Alfuzosin hydrochloride 10 mg/1 · Tablet, Extended release · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-302-01 | 76282030201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01)Marketed from Oct 2, 2012 | |
| 76282-302-05 | 76282030205 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05)Marketed from Oct 2, 2012 | |
| 76282-302-10 | 76282030210 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10)Marketed from Oct 2, 2012 | |
| 76282-302-12 | 76282030212 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12)Marketed from Dec 1, 2022 | |
| 76282-302-90 | 76282030290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)Marketed from Jan 1, 2019 |
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
- Labeler
- Exelan Pharmaceuticals Inc.NDC labeler code 76282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090284
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92daSPL ID 663c0846-dc2c-409f-9fe0-bf2901ff92daSPL set ID f075a897-7bef-4799-b7e2-7e051c461443RxCUI 861132UNII 75046A1XTNUPC 0376282302102, 0376282302010, 0376282302126
- 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
N476282030201followed by a unit qualifier and the quantityPackage 76282-0302-01. 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 tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets USP, is an alpha adrenergic antagonist, indicated for treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: Alfuzosin hydrochloride is not indicated for the treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population.…
Excerpt only. Read the full label for complete information.
About NDC 76282-302
- What is NDC 76282-302?
- 76282-302 is the product NDC for Alfuzosin hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alfuzosin hydrochloride.
- What is the active ingredient?
- Alfuzosin hydrochloride.
- Who is the labeler?
- Exelan Pharmaceuticals Inc., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alfuzosin hydrochloride?
- 14 other product NDCs are listed under this name. See all Alfuzosin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alfuzosin hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-153 | 84386-0153-0184386-0153-0584386-0153-30+2 more |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-2850 | 60505-2850-09 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-967 | 51655-0967-52 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-087 | 51655-0087-52 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-432 | 51655-0432-52 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-155 | 29300-0155-0129300-0155-1329300-0155-19 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-9155 | 63629-9155-0163629-9155-0263629-9155-03+1 more |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | 43353-0945-1643353-0945-3043353-0945-60 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-114 | 57237-0114-0157237-0114-0557237-0114-90 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-249 | 65862-0249-0165862-0249-0565862-0249-30+2 more |
Other NDCs under ANDA 090284
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 | Aphena Pharma Solutions - Tennessee, LLC | 43353-945 |
| Alfuzosin Hydrochloride extended releasealfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-844 |