Sotalol Hydrochloride

Product NDC: 71335-0260
11-digit product format: 713350260
Labeler code: 71335
Product ID: 71335-0260_deff5b14-286a-444c-9ee0-20722efba148
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076140
Marketing category: ANDA
Marketing start: 2003-02-01
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
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…`

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
876214ba-59c4-4acc-a8ad-c6bc91837de8	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	SPL version
71335-0260-1	Sotalol Hydrochloride	60 in 1 BOTTLE	TABLET	60	10
71335-0260-2	Sotalol Hydrochloride	30 in 1 BOTTLE	TABLET	30	10
71335-0260-3	Sotalol Hydrochloride	100 in 1 BOTTLE	TABLET	100	10
71335-0260-4	Sotalol Hydrochloride	90 in 1 BOTTLE	TABLET	90	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0260	SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	9	Current NDC, Legacy NDC, 4 package rows	20241109_876214ba-59c4-4acc-a8ad-c6bc91837de8.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	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 ndc (product): 71335-0260
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1923426	sotalol HCl 80 MG Oral Tablet	PSN	876214ba-59c4-4acc-a8ad-c6bc91837de8	10
1923426	sotalol hydrochloride 80 MG Oral Tablet	SCD	876214ba-59c4-4acc-a8ad-c6bc91837de8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0260-1	71335026001	60 TABLET in 1 BOTTLE (71335-0260-1)	60 tablet	2020-07-14	0000-00-00	No	No	Current
71335-0260-2	71335026002	30 TABLET in 1 BOTTLE (71335-0260-2)	30 tablet	2020-07-14	0000-00-00	No	No	Current
71335-0260-3	71335026003	100 TABLET in 1 BOTTLE (71335-0260-3)	100 tablet	2024-10-30	0000-00-00	No	No	Current
71335-0260-4	71335026004	90 TABLET in 1 BOTTLE (71335-0260-4)	90 tablet	2024-10-30		No	No	Current