NDC 10135-661

Sotalol

Sotalol Hydrochloride

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

• Product ID: 10135-661_43615ac7-ce53-4272-a0b7-32b614c19eb6
• NDC: 10135-661
• Product Type: Human Prescription Drug
• Proprietary Name: Sotalol
• Generic Name: Sotalol Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207428
• Labeler Name: Marlex Pharmaceuticals Inc
• Substance Name: SOTALOL HYDROCHLORIDE
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10135-661-01

100 TABLET in 1 BOTTLE, PLASTIC (10135-661-01)

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10135-661-01 [10135066101]

Sotalol TABLET

• Marketing Category: ANDA
• Application Number: ANDA207428
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-20

NDC 10135-661-50 [10135066150]

Sotalol TABLET

• Marketing Category: ANDA
• Application Number: ANDA207428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-20

Drug Details

Active Ingredients

Ingredient	Strength
SOTALOL HYDROCHLORIDE	80 mg/1

OpenFDA Data

• SPL SET ID: 3c24cdf0-4648-4e5d-993c-1f428ce56a65
• Manufacturer:
  • Marlex Pharmaceuticals Inc
• UNII:
  • HEC37C70XX
• RxNorm Concept Unique ID - RxCUI:
  • 1923424
  • 1923426
  • 1923422
• UPC Code:
  • 0310135662012
  • 0310135661015
  • 0310135663019

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
10135-661	Sotalol	Sotalol Hydrochloride
10135-662	Sotalol	Sotalol Hydrochloride
10135-663	Sotalol	Sotalol Hydrochloride
76385-116	Sotalol	Sotalol
76385-114	Sotalol	Sotalol
76385-115	Sotalol	Sotalol
71335-1189	Sotalol	Sotalol
71610-385	Sotalol	Sotalol
0245-0012	Sorine	Sotalol Hydrochloride
0245-0013	Sorine	Sotalol Hydrochloride
0245-0014	Sorine	Sotalol Hydrochloride
0245-0015	Sorine	Sotalol Hydrochloride
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