Sotalol Hydrochloride

Product NDC: 0603-5769
11-digit product format: 006035769
Labeler code: 0603
Product ID: 0603-5769_2398995d-e533-4306-a436-eb87ff0f064f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA075563
Marketing category: ANDA
Marketing start: 2003-11-07
Marketing end: 2019-06-30
Substance: SOTALOL HYDROCHLORIDE
Active strength: 80 mg/1
Pharmacologic classes: Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83083289-08f8-450a-8eff-9d912bdd64bb	Product name	1	20200505
8b3790df-333b-074c-6570-5beaa3352b77	Product name	2	20190213
424d69b0-0855-4fff-846d-7ced5f554385	Product name	1	20150403
9ab69b37-6a2f-6dca-a9fd-3131946f16f2	Product name	1	20140508

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-5769-21	EA - Each	0603-5769	64390e1f-5c1c-40eb-bc08-60141a7065a4	1	2012-07-24
0603-5769-28	EA - Each	0603-5769	9bea1396-ae10-42da-89f7-a6c8e012f0ac	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOTALOL HYDROCHLORIDE	ACTIVE INGREDIENT	HEC37C70XX	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SOTALOL	ACTIVE MOIETY	A6D97U294I	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SOTALOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HEC37C70XX	SOTALOL HYDROCHLORIDE	959-24-0	SOTALOL HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1923426	sotalol HCl 80 MG Oral Tablet	PSN	d288de0a-913d-4617-aa47-c6201ebf2a0d	3
1923426	sotalol hydrochloride 80 MG Oral Tablet	SCD	d288de0a-913d-4617-aa47-c6201ebf2a0d	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOTALOL HYDROCHLORIDE TABLETS, USP Rx only	Carilion Materials Management	2016-08-04	HUMAN PRESCRIPTION DRUG LABEL	3