Home NDC 71335-2063 Labetalol HCL
Product NDC 71335-2063
11-digit product format 713352063
Labeler code 71335
Product ID 71335-2063_5b73d168-447e-407c-b98f-8347b6cfd9e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200908
Marketing category ANDA
Marketing start 2012-07-24
Substance LABETALOL HYDROCHLORIDE
Active strength 200 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 1 .
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 AB 2012-07-10 A200908-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 A200908-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10
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 · 123 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 2026-02-19 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Labetalol HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LABETALOL HYDROCHLORIDE 200 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 896762 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 71335-2063-1 Labetalol HCL 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 102 71335-2063-2 Labetalol HCL 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 102 71335-2063-3 Labetalol HCL 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2063 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 3 package rows 20241023_d80f884d-2092-4ddc-9e5a-5cce2974d61c.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 71335-2063-1 71335206301 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-1) 2022-03-16 0000-00-00 No No Current 71335-2063-2 71335206302 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-2) 2024-10-07 0000-00-00 No No Current 71335-2063-3 71335206303 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-3) 2022-05-06 0000-00-00 No No Current