Home NDC 71209-083 Labetalol Hydrochloride
Product NDC 71209-083
11-digit product format 712090083
Labeler code 71209
Product ID 71209-083_72d9c230-fb71-4b4b-a4d2-01bf96153ec2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA211325
Marketing category ANDA
Marketing start 2018-05-29
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 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 A211325-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 A211325-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 A211325-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13
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 · 126 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 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211325-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 2019-05-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211325-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2019-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211325-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-13 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 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 · 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 71209-083-03 Labetalol Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 5 71209-083-05 Labetalol Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5 71209-083-10 Labetalol Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 5 71209-083-11 Labetalol Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-083 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20221212_5fba93fc-4580-48c2-a1ec-5d446680adcf.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 71209-083-03 71209008303 60 TABLET, FILM COATED in 1 BOTTLE (71209-083-03) 2018-06-30 0000-00-00 No No Current 71209-083-05 71209008305 100 TABLET, FILM COATED in 1 BOTTLE (71209-083-05) 2022-11-24 0000-00-00 No No Current 71209-083-10 71209008310 500 TABLET, FILM COATED in 1 BOTTLE (71209-083-10) 2022-11-24 0000-00-00 No No Current 71209-083-11 71209008311 1000 TABLET, FILM COATED in 1 BOTTLE (71209-083-11) 2018-06-30 0000-00-00 No No Current