Sotalol Hydrochloride

Product NDC: 72162-1931
11-digit product format: 721621931
Labeler code: 72162
Product ID: 72162-1931_89b33c45-ece8-496f-9c3a-94ebabf73b1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075563
Marketing category: ANDA
Marketing start: 2020-07-24
Substance: SOTALOL HYDROCHLORIDE
Active strength: 80 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075563-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07
A075563-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07
A075563-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07
A075563-004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075563-001	AB
A075563-002	AB
A075563-003	AB
A075563-004	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 5 · 164 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	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075563-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2003-11-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A075563-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075563-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075563-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075563-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075563-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075563-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075563-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075563-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075563-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075563-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075563-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075563-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075563-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sotalol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOTALOL HYDROCHLORIDE	80 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
1923426	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
89b33c45-ece8-496f-9c3a-94ebabf73b1b	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
72162-1931-1	Sotalol Hydrochloride	100 in 1 BOTTLE	TABLET	100		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1931-1	EA - Each	72162-1931	ec3c8dc3-9e14-40db-8104-3c5c0e8ae47a	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1931	SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20240417_89b33c45-ece8-496f-9c3a-94ebabf73b1b.zip

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	9a36d95c-6e93-4e57-befe-b5274f359244	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	667fc1f2-6ccf-4373-89d8-6a064ee7509e	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	10b7b81d-9ce7-4025-8559-fdfa41c8b146	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	A-S Medication Solutions	bbeaba9f-0513-4980-bc29-7f9259a53ecc	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	d6c8f659-1c32-4431-bdb2-3211a1c81006	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e6ea445d-4d7c-4c32-83a7-e7683a56075b	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	b534c632-3b67-4812-a045-3e582eda6de4	2025-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	0fd4afc7-dbf8-46be-9657-aa83bbb2c026	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	89b33c45-ece8-496f-9c3a-94ebabf73b1b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563 ndc (product): 72162-1931
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	6be8c8f2-3977-4b7f-ad45-38b3254afdab	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	f8d0daf3-5eab-44f1-9dec-40e5d9c2bbcf	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	c8ac6351-b1e9-4dd2-82f2-5980814fda15	2023-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	253da1e1-022a-4175-bd7f-e7673cba0767	2022-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075563 application number: ANDA075563

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
1923426	sotalol HCl 80 MG Oral Tablet	PSN	89b33c45-ece8-496f-9c3a-94ebabf73b1b	101
1923426	sotalol hydrochloride 80 MG Oral Tablet	SCD	89b33c45-ece8-496f-9c3a-94ebabf73b1b	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1931-1	72162193101	100 TABLET in 1 BOTTLE (72162-1931-1)	100 tablet	2020-07-24	No	No	Current