Sotalol Hydrochloride

Product NDC: 0615-7888
11-digit product format: 006157888
Labeler code: 0615
Product ID: 0615-7888_2aa92b1f-aaaa-421b-89d2-7391191d307e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA076140
Marketing category: ANDA
Marketing start: 2003-02-01
Marketing end: 0000-00-00
Substance: SOTALOL HYDROCHLORIDE
Active strength: 80 mg/1
Pharmacologic classes: Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-7888		D	Discontinued by firm		2026-08-10
excluded package	package	0615-7888	0615-7888-39	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7888-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7888-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7888-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7888-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7888-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7888-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7888-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7888-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7888-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7888-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7888-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7888-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7888-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7888-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7888-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A076140-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26
A076140-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26
A076140-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26
A076140-004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076140-001	AB
A076140-002	AB
A076140-003	AB
A076140-004	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	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076140-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2002-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2002-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2002-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2002-09-26	`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	A076140-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076140-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076140-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076140-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076140-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076140-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076140-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076140-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076140-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076140-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076140-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076140-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076140-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7888-39	2021-08-31	C162847	48780-1	9d75b9d0-7ad4-f424-e053-dadaa90a57ce	Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mg
0615-7888-39	2020-01-31	C162847	48780-1	9d75b9d0-7ad4-f424-e053-dadaa90a57ce	Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOTALOL HYDROCHLORIDE	ACTIVE INGREDIENT	HEC37C70XX	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SOTALOL	ACTIVE MOIETY	A6D97U294I	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

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	American Health Packaging	4614480b-b36e-4dbd-9fc0-d083890d297d	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	AvPAK	bcbc1624-283e-732f-e053-2995a90a8f11	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Northwind Health Company, LLC	fe82c866-03d4-e07b-e053-6394a90a8b1e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Major Pharmaceuticals	866e5717-3de2-4f19-b7c7-2275caeef78b	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Cardinal Health 107, LLC	4f5902e1-9f9f-4c6b-817d-2efbb5e28061	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	bc35a3e8-681c-4fe8-96cd-b2a62f024c4b	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	27c73b70-99e8-40e8-8aa9-36d3addd3bb4	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	876214ba-59c4-4acc-a8ad-c6bc91837de8	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	6674d53a-7137-4822-8841-4982f702a1b8	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Apotex Corp.	1a56c82e-7ecd-43b0-2899-f89e47adf7db	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1f2ee505-eb90-885d-e063-6394a90a46a1	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	A-S Medication Solutions	7cb4879f-31e7-4862-bc0c-d439e592d81c	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5e005309-4eca-4536-8743-c6ed9e5b3195	2023-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	517824b1-11be-40a9-9066-d1a6a32a2938	2023-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076140 application number: ANDA076140

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2015-09-30	HUMAN PRESCRIPTION DRUG LABEL	1