Home NDC 0143-9623 Labetalol Hydrochloride
Product NDC 0143-9623
11-digit product format 001439623
Labeler code 0143
Product ID 0143-9623_069ca72e-bf5a-440a-9169-19f1ac7f7126
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075303
Marketing category ANDA
Marketing start 1999-11-29
Substance LABETALOL HYDROCHLORIDE
Active strength 5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075303-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075303-001 AP
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 2 · 42 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 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075303-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1999-05-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 5 mg/mL
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 896771 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 0143-9623-01 Labetalol Hydrochloride 1 in 1 BOX, UNIT-DOSE INJECTION 1 4 0143-9623-01 Labetalol Hydrochloride 40 mL in 1 VIAL INJECTION 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9623 LABETALOL HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240711_30f9fdef-8781-4327-9a8d-812cb31ff041.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 Units Marketing start Marketing end Sample Exclude flag Status 0143-9623-01 00143962301 1 VIAL in 1 BOX, UNIT-DOSE (0143-9623-01) / 40 mL in 1 VIAL 1 vial 1999-11-29 0000-00-00 No No Current