Sotalol Hydrochloride

Product NDC: 0615-5552
11-digit product format: 006155552
Labeler code: 0615
Product ID: 0615-5552_7d61f28c-fe77-46c1-ace4-34b701ce4e5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA075563
Marketing category: ANDA
Marketing start: 2003-11-07
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	0615-5552		D	Discontinued by firm		2026-08-10
excluded package	package	0615-5552	0615-5552-39	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 · 38 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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	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	0615-5552-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0615-5552-39	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0615-5552-39	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0615-5552-39	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0615-5552-39	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	0615-5552-39	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	0615-5552-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-5552-39	I	Inactivated by FDA	`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
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-5552-39	2022-11-22	C162847	48780-1	9855d018-e795-cd31-e053-dbdaa90ab51a	SOTALOL HYDROCHLORIDE TABLETS, USP Rx only
0615-5552-39	2019-11-27	C162847	48780-1	9855d018-e795-cd31-e053-dbdaa90ab51a	SOTALOL HYDROCHLORIDE TABLETS, USP Rx only

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]	2
SOTALOL	ACTIVE MOIETY	A6D97U294I	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SOTALOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2

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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOTALOL HYDROCHLORIDE TABLETS, USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2012-11-14	HUMAN PRESCRIPTION DRUG LABEL	2