BETAPACE

Product NDC: 70515-109
11-digit product format: 705150109
Labeler code: 70515
Product ID: 70515-109_1b3fb38e-5546-4a55-866f-d2e2ffadaed8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sotalol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Covis Pharma US, Inc
Application: NDA019865
Marketing category: NDA
Marketing start: 2016-09-01
Marketing end: 0000-00-00
Substance: SOTALOL HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70515-109		I	Inactivated by FDA		2026-08-10
excluded package	package	70515-109	70515-109-10	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 · 18 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70515-109-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70515-109-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70515-109-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70515-109-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70515-109-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70515-109-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70515-109-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70515-109-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70515-109-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019865-001	BETAPACE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RLD	1992-10-30
N019865-002	BETAPACE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30
N019865-003	BETAPACE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	RLD	1992-10-30
N019865-004	BETAPACE	SOTALOL HYDROCHLORIDE	320MG	TABLET / ORAL			1992-10-30
N019865-005	BETAPACE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD	1994-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019865-001	AB
N019865-002	AB
N019865-003	AB
N019865-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-001	BETAPACE	80MG	TABLET / ORAL	AB	RLD	1992-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-002	BETAPACE	160MG	TABLET / ORAL	AB	RLD, RS	1992-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-003	BETAPACE	240MG	TABLET / ORAL	AB	RLD	1992-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-004	BETAPACE	320MG	TABLET / ORAL			1992-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-005	BETAPACE	120MG	TABLET / ORAL	AB	RLD	1994-04-20	`5bbf6a4d5a75…`

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	N019865-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019865-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019865-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019865-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019865-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019865-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019865-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019865-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019865-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019865-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019865-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019865-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019865-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019865-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019865-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019865-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019865-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019865-005	AB	1	`d06236e962d9…`

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
70515-109-10	2025-01-30	C162847	48780-1	2cef2736-8037-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use BETAPACE ® /BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral use BETAPACE AF (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
70515-109-10	BETAPACE	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-109-10	EA - Each	70515-109	32bae903-c9c2-4e39-85b2-8b0dd12fa7c8	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-109	BETAPACE (SOTALOL HYDROCHLORIDE) TABLET BETAPACE AF (SOTALOL HYDROCHLORIDE) TABLET [COVIS PHARMA US, INC]	6	Legacy NDC, 1 package rows	20230629_afce2787-8899-4098-87c8-f1e8dd19e6dd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BETAPACE	SOTALOL HYDROCHLORIDE	Legacy Pharma USA, Inc.	a6a7702f-36c9-45db-b640-453dc324baee	2024-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019865 application number: NDA019865

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
1923423	Betapace 120 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923425	Betapace 160 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923427	Betapace 80 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922721	Betapace AF 120 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922764	Betapace AF 160 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922766	Betapace AF 80 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923422	sotalol HCl 120 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923424	sotalol HCl 160 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923426	sotalol HCl 80 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922720	sotalol HCl AF 120 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922763	sotalol HCl AF 160 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922765	sotalol HCl AF 80 MG Oral Tablet	PSN	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922721	Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922764	Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922766	Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923423	sotalol hydrochloride 120 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923425	sotalol hydrochloride 160 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923427	sotalol hydrochloride 80 MG Oral Tablet [Betapace]	SBD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922720	Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922763	Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922765	Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923422	sotalol hydrochloride 120 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923424	sotalol hydrochloride 160 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923426	sotalol hydrochloride 80 MG Oral Tablet	SCD	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922721	Atrial Fibrillation Betapace 120 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922764	Atrial Fibrillation Betapace 160 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922766	Atrial Fibrillation Betapace 80 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923423	Betapace 120 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923425	Betapace 160 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1923427	Betapace 80 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922721	Betapace AF 120 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922764	Betapace AF 160 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922766	Betapace AF 80 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922763	sotalol HCl AF 160 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922765	sotalol HCl AF 80 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6
1922720	sotalol hydrochloride AF 120 MG Oral Tablet	SY	afce2787-8899-4098-87c8-f1e8dd19e6dd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70515-109-10	70515010910	100 TABLET in 1 BOTTLE (70515-109-10)	100 tablet	2016-09-01	0000-00-00	No	No	Current