Home NDC 50090-7156 Labetalol hydrochloride
Product NDC 50090-7156
11-digit product format 500907156
Labeler code 50090
Product ID 50090-7156_600f7629-8912-496d-872b-753dcdea425a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA075133
Marketing category ANDA
Marketing start 1998-08-03
Substance LABETALOL HYDROCHLORIDE
Active strength 300 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 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 300 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-7156-0 50090715600 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-0) 2024-04-30 No No Current 50090-7156-1 50090715601 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-1) 2024-04-30 No No Current