Sorine

Product NDC: 0245-0012
11-digit product format: 002450012
Labeler code: 0245
Product ID: 0245-0012_f761800d-2a52-4ddd-995f-0257de6d7463
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sotalol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, Inc.
Application: ANDA075500
Marketing category: ANDA
Marketing start: 2011-02-15
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0245-0012		D	Discontinued by firm	2026-08-10
excluded package	package	0245-0012	0245-0012-01	D	Discontinued by firm	2026-08-10
excluded package	package	0245-0012	0245-0012-11	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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0245-0012-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0245-0012-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0245-0012-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0245-0012-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0245-0012-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0245-0012-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0245-0012-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0245-0012-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0245-0012-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0245-0012-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0245-0012-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0245-0012-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0245-0012-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0245-0012-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0245-0012-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0245-0012-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0245-0012-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0245-0012-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0245-0012-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0245-0012-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0245-0012-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0245-0012-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0245-0012-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0245-0012-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075500-001	SORINE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2001-04-27
A075500-002	SORINE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2001-04-27
A075500-003	SORINE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2001-04-27
A075500-004	SORINE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2001-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075500-001	AB
A075500-002	AB
A075500-003	AB
A075500-004	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	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`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	A075500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0245-0012-01	EA - Each	0245-0012	a3103433-28f4-4916-b494-c06fd0cbe664	1	2012-07-24
0245-0012-89	EA - Each	0245-0012	cc663502-66bd-4fda-b72c-daf4c1fb77d1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sotalol Hydrochloride	ACTIVE INGREDIENT	HEC37C70XX	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
Sotalol	ACTIVE MOIETY	A6D97U294I	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	SORINE (SOTALOL HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]	5
Sotalol Hydrochloride	ACTIVE INGREDIENT	HEC37C70XX	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
Sotalol	ACTIVE MOIETY	A6D97U294I	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	SORINE (SOTALOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	3

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 HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	44d0ce4c-de00-4151-ad7f-48a59040a9b0	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	56dd490f-4d78-447c-a460-f55587e8a764	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	14ee4756-52f2-4bbf-bd79-663839ecb1c5	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	db9b0b36-4c00-45b6-a50a-e08d7c61a17c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	56326224-fc80-4b89-8ba3-70cb873173b4	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0245-0012-01	00245001201	100 BLISTER PACK in 1 CARTON (0245-0012-01) > 1 TABLET in 1 BLISTER PACK (0245-0012-89)	100 blister pack	2011-02-15	0000-00-00	No	No	Current
0245-0012-11	00245001211	100 TABLET in 1 BOTTLE (0245-0012-11)	100 tablet	2011-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sorine	Upsher-Smith Laboratories, Inc.	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	10
SORINE ® (Sotalol Hydrochloride Tablets, USP)	Cardinal Health	2020-11-25	HUMAN PRESCRIPTION DRUG LABEL	10