Home NDC 63629-2053 Labetalol Hydrochloride
Product NDC 63629-2053
11-digit product format 636292053
Labeler code 63629
Product ID 63629-2053_887d805b-d3d6-4b36-aa21-992df0c0201d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207863
Marketing category ANDA
Marketing start 2019-05-24
Substance LABETALOL HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-2053-1 Labetalol Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2053 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20230306_d073b03d-057d-44eb-a3a7-8f439b965c8a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-2053-1 63629205301 500 TABLET, FILM COATED in 1 BOTTLE (63629-2053-1) 2021-02-02 0000-00-00 No No Current