BETAPACE AF

Product NDC: 70515-116
11-digit product format: 705150116
Labeler code: 70515
Product ID: 70515-116_1b3fb38e-5546-4a55-866f-d2e2ffadaed8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sotalol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Covis Pharma US, Inc
Application: NDA021151
Marketing category: NDA
Marketing start: 2016-09-01
Marketing end: 0000-00-00
Substance: SOTALOL HYDROCHLORIDE
Active strength: 160 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	70515-116		I	Inactivated by FDA		2026-08-10
excluded package	package	70515-116	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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	70515-116-06	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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021151-001	BETAPACE AF	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RLD	2000-02-22
N021151-002	BETAPACE AF	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD	2000-02-22
N021151-003	BETAPACE AF	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22
N021151-005	BETAPACE AF	SOTALOL HYDROCHLORIDE	100MG	TABLET / ORAL			2003-03-14
N021151-006	BETAPACE AF	SOTALOL HYDROCHLORIDE	40MG	TABLET / ORAL			2003-04-02
N021151-007	BETAPACE AF	SOTALOL HYDROCHLORIDE	60MG	TABLET / ORAL			2003-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021151-001	AB
N021151-002	AB
N021151-003	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 7 · 246 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	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`2680178bc6a6…`

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	N021151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021151-001	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
70515-116-06	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
70515-116-06	BETAPACE AF	60 in 1 BOTTLE	TABLET	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-116-06	EA - Each	70515-116	c122aa72-861b-46e7-87bc-b939fab57f24	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-116	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

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
70515-116-06	70515011606	60 TABLET in 1 BOTTLE (70515-116-06)	60 tablet	2016-09-01	0000-00-00	No	No	Current