Prescription drug · ANDA
Alfuzosin hydrochloride NDC 63629-9155
Alfuzosin hydrochloride 10 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9155-1 | 63629915501 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-1)Marketed from Apr 29, 2022 | |
| 63629-9155-2 | 63629915502 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-2)Marketed from Apr 29, 2022 | |
| 63629-9155-3 | 63629915503 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-3)Marketed from Apr 29, 2022 | |
| 63629-9155-4 | 63629915504 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-4)Marketed from Apr 29, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-9155_f10b905b-346c-493f-ad51-54c0b9e0d3a4SPL ID f10b905b-346c-493f-ad51-54c0b9e0d3a4SPL set ID c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbdaRxCUI 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
N463629915501followed by a unit qualifier and the quantityPackage 63629-9155-01. 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.
About NDC 63629-9155
- What is NDC 63629-9155?
- 63629-9155 is the product NDC for Alfuzosin hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 4 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 | 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 |
| 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 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 | Unichem Pharmaceuticals (USA), Inc. | 29300-155 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-967 |