Home NDC 71205-095 Labetalol hydrochloride
Product NDC 71205-095
11-digit product format 712050095
Labeler code 71205
Product ID 71205-095_5179866d-f336-4e03-85b0-972fbedb6b9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA075133
Marketing category ANDA
Marketing start 1998-08-03
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 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 A075133-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 A075133-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 A075133-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03
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 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Labetalol hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LABETALOL HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1GEV3BAW9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896758 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-095-30 Labetalol hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4 71205-095-60 Labetalol hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 4 71205-095-90 Labetalol hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-095 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 3 package rows 20221104_c0301841-e209-4242-bace-58a20e6dd01b.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 · 4 matching rows.
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 71205-095-30 71205009530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30) 2018-08-01 0000-00-00 No No Current 71205-095-60 71205009560 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60) 2018-08-01 0000-00-00 No No Current 71205-095-90 71205009590 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90) 2018-08-01 0000-00-00 No No Current