NDC 0378-0523

Bisoprolol Fumarate

Bisoprolol Fumarate

Bisoprolol Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Bisoprolol Fumarate.

• Product ID: 0378-0523_78d1a125-950d-4309-be9e-642adb463b17
• NDC: 0378-0523
• Product Type: Human Prescription Drug
• Proprietary Name: Bisoprolol Fumarate
• Generic Name: Bisoprolol Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075831
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: BISOPROLOL FUMARATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-0523-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0523-01)

• Marketing Start Date: 2012-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0523-93 [00378052393]

Bisoprolol Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075831
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-09-24
• Marketing End Date: 2020-11-30

NDC 0378-0523-01 [00378052301]

Bisoprolol Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075831
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-09-24
• Marketing End Date: 2020-11-30

NDC 0378-0523-25 [00378052325]

Bisoprolol Fumarate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075831
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-09-24
• Marketing End Date: 2017-12-04

Drug Details

Active Ingredients

Ingredient	Strength
BISOPROLOL FUMARATE	5 mg/1

OpenFDA Data

• SPL SET ID: 621d9058-804a-4f46-a047-ea6e432eee49
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • UR59KN573L
• RxNorm Concept Unique ID - RxCUI:
  • 854905
  • 854901

Pharmacological Class

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

NDC Crossover Matching brand name "Bisoprolol Fumarate" or generic name "Bisoprolol Fumarate"

NDC	Brand Name	Generic Name
0093-5270	Bisoprolol Fumarate	Bisoprolol Fumarate
0093-5271	Bisoprolol Fumarate	Bisoprolol Fumarate
0185-0771	bisoprolol fumarate	bisoprolol fumarate
0185-0774	bisoprolol fumarate	bisoprolol fumarate
0378-0523	Bisoprolol Fumarate	bisoprolol fumarate
0378-0524	Bisoprolol Fumarate	bisoprolol fumarate
15955-373	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
15955-374	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
16714-529	Bisoprolol Fumarate	Bisoprolol Fumarate
16714-530	Bisoprolol Fumarate	Bisoprolol Fumarate
21695-667	Bisoprolol Fumarate	Bisoprolol fumarate
21695-670	Bisoprolol Fumarate	Bisoprolol fumarate
29300-126	Bisoprolol Fumarate	Bisoprolol fumarate
29300-127	Bisoprolol Fumarate	Bisoprolol fumarate
50268-127	Bisoprolol Fumarate	Bisoprolol Fumarate
51407-645	Bisoprolol Fumarate	Bisoprolol Fumarate
51407-646	Bisoprolol Fumarate	Bisoprolol Fumarate
57237-132	Bisoprolol Fumarate	Bisoprolol Fumarate
57237-133	Bisoprolol Fumarate	Bisoprolol Fumarate
60687-679	Bisoprolol Fumarate	Bisoprolol fumarate
61919-787	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
62332-603	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
62332-604	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
63187-871	Bisoprolol Fumarate	Bisoprolol fumarate
63629-5173	Bisoprolol Fumarate	Bisoprolol fumarate
65862-086	Bisoprolol Fumarate	Bisoprolol Fumarate
68071-1582	Bisoprolol Fumarate	Bisoprolol Fumarate
68084-487	bisoprolol fumarate	bisoprolol fumarate
68151-4504	Bisoprolol Fumarate	Bisoprolol Fumarate
68788-6775	Bisoprolol Fumarate	Bisoprolol Fumarate
65862-087	Bisoprolol Fumarate	Bisoprolol Fumarate
52817-270	Bisoprolol	Bisoprolol fumarate
52817-271	Bisoprolol	Bisoprolol fumarate
63629-6907	Bisoprolol	Bisoprolol fumarate