Home NDC 23155-723 Labetalol Hydrochloride
Product NDC 23155-723
11-digit product format 231550723
Labeler code 23155
Product ID 23155-723_50a37968-605e-481b-af03-db963542a6c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA074787
Marketing category ANDA
Marketing start 2020-02-22
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 2027-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074787-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 A074787-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 A074787-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 A074787-004 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2026-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 128 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 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074787-004 LABETALOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2026-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074787-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074787-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074787-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Labetalol Hydrochloride
Listing expiration 2027-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896758 Internal RxNorm lookup 896762 Internal RxNorm lookup 896766 Internal RxNorm lookup 896983 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 23155-723-01 Labetalol Hydrochloride 100 in 1 BOTTLE TABLET 100 6 23155-723-05 Labetalol Hydrochloride 500 in 1 BOTTLE TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-723 LABETALOL HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20220415_bf84ebae-3c91-4448-b1db-8e5ed3053866.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 Units Marketing start Marketing end Sample Exclude flag Status 23155-723-01 23155072301 100 TABLET in 1 BOTTLE (23155-723-01) 100 tablet 2020-02-22 0000-00-00 No No Current 23155-723-05 23155072305 500 TABLET in 1 BOTTLE (23155-723-05) 500 tablet 2020-02-22 0000-00-00 No No Current