NDC 0378-5124

Sotalol Hydrochloride

Sotalol Hydrochloride

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

• Product ID: 0378-5124_3f4eac4d-6f01-4e6a-8144-65448519efdb
• NDC: 0378-5124
• Product Type: Human Prescription Drug
• Proprietary Name: Sotalol Hydrochloride
• Generic Name: Sotalol Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2007-02-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077616
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: SOTALOL HYDROCHLORIDE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-5124-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-5124-01)

• Marketing Start Date: 2007-02-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5124-01 [00378512401]

Sotalol Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA077616
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-02-20

Drug Details

Active Ingredients

Ingredient	Strength
SOTALOL HYDROCHLORIDE	120 mg/1

OpenFDA Data

• SPL SET ID: 6524fdc2-f931-463d-ba77-b6ab1688fe45
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • HEC37C70XX
• RxNorm Concept Unique ID - RxCUI:
  • 1922720
  • 1922765
  • 1922763

Pharmacological Class

• Antiarrhythmic [EPC]
• Cardiac Rhythm Alteration [PE]
• Adrenergic beta-Antagonists [MoA]
• Antiarrhythmic [EPC]
• Cardiac Rhythm Alteration [PE]
• Adrenergic beta-Antagonists [MoA]

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

NDC	Brand Name	Generic Name
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride
0185-0170	sotalol hydrochloride	sotalol hydrochloride
0185-0171	sotalol hydrochloride	sotalol hydrochloride
0185-0174	sotalol hydrochloride	sotalol hydrochloride
0185-0177	sotalol hydrochloride	sotalol hydrochloride
0378-5123	Sotalol Hydrochloride	sotalol hydrochloride
0378-5124	Sotalol Hydrochloride	sotalol hydrochloride
0378-5125	Sotalol Hydrochloride	sotalol hydrochloride
0603-5769	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5770	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5771	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5772	Sotalol Hydrochloride	Sotalol Hydrochloride
0615-5552	Sotalol Hydrochloride	Sotalol Hydrochloride
0615-7888	Sotalol Hydrochloride	Sotalol Hydrochloride
0904-7143	Sotalol Hydrochloride	Sotalol Hydrochloride
68071-2014	Sotalol Hydrochloride	Sotalol Hydrochloride
68084-654	Sotalol Hydrochloride	Sotalol Hydrochloride
68151-2702	Sotalol Hydrochloride	Sotalol Hydrochloride
69724-112	Sotalol hydrochloride	Sotalol hydrochloride
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride
71335-0260	Sotalol Hydrochloride	Sotalol Hydrochloride
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride
71610-074	Sotalol Hydrochloride	Sotalol Hydrochloride
21695-397	sotalol hydrochloride	sotalol hydrochloride
42806-121	Sotalol Hydrochloride	Sotalol Hydrochloride
43063-133	sotalol hydrochloride	sotalol hydrochloride
42806-122	Sotalol Hydrochloride	Sotalol Hydrochloride
42806-123	Sotalol Hydrochloride	Sotalol Hydrochloride
43353-616	Sotalol Hydrochloride	Sotalol Hydrochloride
50090-1299	Sotalol Hydrochloride	Sotalol Hydrochloride
53217-011	Sotalol Hydrochloride	Sotalol Hydrochloride
60429-751	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0222	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0081	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0224	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0080	Sotalol Hydrochloride	Sotalol Hydrochloride
60429-749	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0223	Sotalol Hydrochloride	Sotalol Hydrochloride
60429-748	Sotalol Hydrochloride	Sotalol Hydrochloride
60429-750	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0082	Sotalol Hydrochloride	Sotalol Hydrochloride
60505-0159	Sotalol Hydrochloride	Sotalol Hydrochloride
63187-426	Sotalol Hydrochloride	Sotalol Hydrochloride
63187-804	Sotalol Hydrochloride	Sotalol Hydrochloride
63629-4719	Sotalol Hydrochloride	Sotalol Hydrochloride
71335-1125	Sotalol Hydrochloride	Sotalol Hydrochloride
71610-294	Sotalol Hydrochloride	Sotalol Hydrochloride