Alfuzosin Hydrochloride
- Product NDC
- 65862-249
- 11-digit product format
- 658620249
- Labeler code
- 65862
- Product ID
- 65862-249_d8c832c1-9455-4647-822a-ee4f35ba0560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alfuzosin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA079060
- Marketing category
- ANDA
- Marketing start
- 2012-08-30
- Substance
- ALFUZOSIN HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alfuzosin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALFUZOSIN HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 75046A1XTN |
| Rxcui | 861132 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-249-01 | Alfuzosin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 13 |
| 65862-249-05 | Alfuzosin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 13 |
| 65862-249-30 | Alfuzosin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 13 |
| 65862-249-90 | Alfuzosin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 13 |
| 65862-249-99 | Alfuzosin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALFUZOSIN HYDROCHLORIDE | ACTIVE INGREDIENT | 75046A1XTN | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| ALFUZOSIN | ACTIVE MOIETY | 90347YTW5F | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | INACTIVE INGREDIENT | Z135WT9208 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-249 | ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 13 | Current NDC, Legacy NDC, 5 package rows | 20240109_d163369b-e44b-4591-b166-7ddd0c1c13c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-249-01 | 65862024901 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01) | 2012-08-30 | 0000-00-00 | No | No | Current |
| 65862-249-05 | 65862024905 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05) | 2012-08-30 | 0000-00-00 | No | No | Current |
| 65862-249-26 | 65862024926 | 2500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-249-26) | 30-AUG-12 | | | | Current |
| 65862-249-30 | 65862024930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30) | 2012-08-30 | 0000-00-00 | No | No | Current |
| 65862-249-90 | 65862024990 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90) | 2012-08-30 | 0000-00-00 | No | No | Current |
| 65862-249-99 | 65862024999 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99) | 2012-08-30 | 0000-00-00 | No | No | Current |