Home NDC 70515-119-06 BETAPACE AF
Product NDC 70515-119
Requested package NDC 70515-119-06
11-digit product format 705150119
Labeler code 70515
Product ID 70515-119_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 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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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 · 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.
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70515-119-06 BETAPACE AF 60 in 1 BOTTLE TABLET 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70515-119 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70515-119-06 70515011906 60 TABLET in 1 BOTTLE (70515-119-06) 60 tablet 2016-09-01 0000-00-00 No No Current