NDC 0378-5005

Alfuzosin Hydrochloride

Alfuzosin

Alfuzosin Hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Alfuzosin Hydrochloride.

• Product ID: 0378-5005_0cb40738-5a0d-456f-b8cb-3aa25159e520
• NDC: 0378-5005
• Product Type: Human Prescription Drug
• Proprietary Name: Alfuzosin Hydrochloride
• Generic Name: Alfuzosin
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2011-08-09
• Marketing End Date: 2019-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079014
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ALFUZOSIN HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0378-5005-77

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5005-77)

• Marketing Start Date: 2011-08-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5005-77 [00378500577]

Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-08-09
• Marketing End Date: 2019-10-31

NDC 0378-5005-05 [00378500505]

Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-08-09
• Marketing End Date: 2014-06-30

Drug Details

Active Ingredients

Ingredient	Strength
ALFUZOSIN HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: be485a4c-aba3-43fa-9904-403595bc3f96
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 75046A1XTN
• RxNorm Concept Unique ID - RxCUI:
  • 861132

Pharmacological Class

• Adrenergic alpha-Antagonists [MoA]
• alpha-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "Alfuzosin Hydrochloride" or generic name "Alfuzosin"

NDC	Brand Name	Generic Name
0378-5005	Alfuzosin Hydrochloride	alfuzosin
0440-5000	Alfuzosin hydrochloride	Alfuzosin hydrochloride
13668-021	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride
31722-302	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
33261-994	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
42291-110	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
43353-746	Alfuzosin Hydrochloride	alfuzosin
43353-945	Alfuzosin hydrochloride	Alfuzosin hydrochloride
47335-956	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
55648-738	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
57237-114	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
60505-2850	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
61919-349	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE
63629-2353	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
63629-2354	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
63629-7907	Alfuzosin hydrochloride	Alfuzosin hydrochloride
63629-9155	Alfuzosin hydrochloride	Alfuzosin hydrochloride
63629-9295	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
64679-738	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
65862-249	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
69097-844	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
70934-306	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
70934-961	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride
76282-302	Alfuzosin hydrochloride	Alfuzosin hydrochloride
71335-1529	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride