Sotalol

Product NDC: 71610-385
Requested package NDC: 71610-385-80
11-digit product format: 716100385
Labeler code: 71610
Product ID: 71610-385_6609ed04-1ad3-425a-94da-d6a8108bc77c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA207428
Marketing category: ANDA
Marketing start: 2018-10-01
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: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-385	71610-385-80	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-385-80	2023-01-30	C162847	48780-1	f386c64a-16af-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS. SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-385-80	Sotalol	180 in 1 BOTTLE, PLASTIC	TABLET	180		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-385-80	EA - Each	71610-385	e15a9310-1543-41a1-a1e7-660d886df66e	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-385	SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20200303_e643b7b2-92b2-4b61-95c3-04a4887dc902.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 · 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

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	e643b7b2-92b2-4b61-95c3-04a4887dc902	1
1923426	sotalol hydrochloride 80 MG Oral Tablet	SCD	e643b7b2-92b2-4b61-95c3-04a4887dc902	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-385-80	71610038580	180 TABLET in 1 BOTTLE, PLASTIC (71610-385-80)	180 tablet	2020-01-10	0000-00-00	No	No	Current