Home NDC 70934-574-60 Labetalol Hydrochloride
Product NDC 70934-574
Requested package NDC 70934-574-60
11-digit product format 709340574
Labeler code 70934
Product ID 70934-574_abfc2290-6c54-cae9-e053-2995a90acb54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application ANDA207863
Marketing category ANDA
Marketing start 2020-02-26
Marketing end 0000-00-00
Substance LABETALOL HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 15 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207863-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 A207863-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 A207863-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207863-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207863-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-02-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70934-574-60 70934057460 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-574-60) 2020-03-19 0000-00-00 No No Current