Home NDC 33342-517 Labetalol Hydrochloride
Product NDC 33342-517
11-digit product format 333420517
Labeler code 33342
Product ID 33342-517_366134cd-6244-45fc-99f1-0193a0221b3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA217949
Marketing category ANDA
Marketing start 2025-09-23
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 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 A217949-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-09-23 A217949-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-09-23 A217949-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2025-09-23
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.
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 A217949-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217949-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217949-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2025-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217949-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217949-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217949-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2025-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217949-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217949-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217949-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2025-09-23 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217949-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-09-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217949-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-09-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217949-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2025-09-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896758 Internal RxNorm lookup 896762 Internal RxNorm lookup 896766 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 33342-517-11 Labetalol Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 33342-517-15 Labetalol Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 1
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 Sample Exclude flag Status 33342-517-11 33342051711 100 TABLET, FILM COATED in 1 BOTTLE (33342-517-11) 2025-09-23 No No Current 33342-517-15 33342051715 500 TABLET, FILM COATED in 1 BOTTLE (33342-517-15) 2025-09-23 No No Current