Prescription drug · ANDA
Alfuzosin Hydrochloride NDC 65862-249
Alfuzosin hydrochloride 10 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-249-01 | 65862024901 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01)Marketed from Aug 30, 2012 | |
| 65862-249-05 | 65862024905 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05)Marketed from Aug 30, 2012 | |
| 65862-249-30 | 65862024930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30)Marketed from Aug 30, 2012 | |
| 65862-249-90 | 65862024990 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90)Marketed from Aug 30, 2012 | |
| 65862-249-99 | 65862024999 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99)Marketed from Aug 30, 2012 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079060
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 65862-249_ed1ad687-f3a5-465e-915f-9ea4fcf63ed7SPL ID ed1ad687-f3a5-465e-915f-9ea4fcf63ed7SPL set ID d163369b-e44b-4591-b166-7ddd0c1c13c0RxCUI 861132UNII 75046A1XTNUPC 0365862249302
- 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
N465862024901followed by a unit qualifier and the quantityPackage 65862-0249-01. 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 are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.…
Excerpt only. Read the full label for complete information.
About NDC 65862-249
- What is NDC 65862-249?
- 65862-249 is the product NDC for Alfuzosin Hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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, Extended releaseOral | Exelan Pharmaceuticals Inc. | 76282-302 | 76282-0302-0176282-0302-0576282-0302-10+2 more |
| 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 |
Other NDCs under ANDA 079060
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, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-087 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-114 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2578 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-153 |