Home NDC 50090-1291 Labetalol HCL
Product NDC 50090-1291
11-digit product format 500901291
Labeler code 50090
Product ID 50090-1291_e1aaf974-aad8-451d-a163-3bba37bd0b1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA200908
Marketing category ANDA
Marketing start 2012-07-24
Marketing end 0000-00-00
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 2022-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1291-1 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1291-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1291-1 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1291-0 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A200908-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 A200908-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 A200908-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10
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 · 129 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 2026-09-14 22:38:34 2026-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-1291-0 2023-02-07 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-1 2023-02-07 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-0 2023-01-30 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-1 2023-01-30 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-0 2020-02-14 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-1 2020-02-14 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-0 2020-01-31 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only 50090-1291-1 2020-01-31 Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1291-0 Labetalol HCL 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 45 50090-1291-1 Labetalol HCL 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 45
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1291 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 43 Legacy NDC, 2 package rows 20250406_312dde0d-5147-483e-968f-4e0d46114176.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 · 1 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 50090-1291-0 50090129100 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-0) 2014-11-28 0000-00-00 No No Current 50090-1291-1 50090129101 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-1) 2015-08-06 0000-00-00 No No Current