Sotalol

Product NDC: 72162-2523
11-digit product format: 721622523
Labeler code: 72162
Product ID: 72162-2523_ccf71ac1-c65a-4da7-ad32-c685615c900b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207428
Marketing category: ANDA
Marketing start: 2017-12-06
Substance: SOTALOL HYDROCHLORIDE
Active strength: 160 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207428-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21
A207428-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21
A207428-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207428-001	AB
A207428-002	AB
A207428-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207428-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sotalol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOTALOL HYDROCHLORIDE	160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HEC37C70XX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1923424	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5962c4ee-c8f7-4e38-ab8c-4848c7644362	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2523-1	Sotalol	100 in 1 BOTTLE	TABLET	100		101

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	c824f6b2-80c5-45a6-a491-4c14c9f5e33d	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	56879738-8662-4f5c-8386-761ab2b5e46f	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	282b48b2-f9ff-474a-b01e-68a9ce5edf07	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	51cebe16-4496-4f49-b2db-b7b21c08fa23	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	5962c4ee-c8f7-4e38-ab8c-4848c7644362	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428 ndc (product): 72162-2523

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1923424	sotalol HCl 160 MG Oral Tablet	PSN	5962c4ee-c8f7-4e38-ab8c-4848c7644362	101
1923424	sotalol hydrochloride 160 MG Oral Tablet	SCD	5962c4ee-c8f7-4e38-ab8c-4848c7644362	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2523-1	72162252301	100 TABLET in 1 BOTTLE (72162-2523-1)	100 tablet	2017-12-06	No	No	Current