Home NDC 0409-2339 Labetalol Hydrochloride
Product NDC 0409-2339
11-digit product format 004092339
Labeler code 0409
Product ID 0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA075239
Marketing category ANDA
Marketing start 2005-10-18
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 A075239-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075239-001 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 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075239-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 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 1234256 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 0409-2339-24 Labetalol Hydrochloride 4 mL in 1 CARTRIDGE INJECTION, SOLUTION 4 20 0409-2339-34 Labetalol Hydrochloride 10 in 1 PACKAGE INJECTION, SOLUTION 10 20 0409-2339-34 Labetalol Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 ANHYDROUS DEXTROSE INACTIVE INGREDIENT 5SL0G7R0OK LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 ANHYDROUS DEXTROSE INACTIVE INGREDIENT 5SL0G7R0OK LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2339 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 20 Current NDC, Legacy NDC, 3 package rows 20210531_d3579d45-a964-40fe-e3a2-a3a997c8b7b9.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 · 2 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 0409-2339-24 00409233924 4 mL in 1 CARTRIDGE 4 ml Historical 0409-2339-34 00409233934 10 CARTON in 1 PACKAGE (0409-2339-34) / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24) 10 carton 2005-10-18 0000-00-00 No No Current