Home NDC 0409-0125 Labetalol Hydrochloride
Product NDC 0409-0125
11-digit product format 004090125
Labeler code 0409
Product ID 0409-0125_c1772ea4-65eb-4f27-8e33-3de06278acfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA075240
Marketing category ANDA
Marketing start 2023-08-07
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 1 .
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 A075240-001 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 A075240-001 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 · 41 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 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075240-001 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 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075240-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1999-11-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Labetalol Hydrochloride
Listing expiration 2027-12-31 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 0409-0125-01 Labetalol Hydrochloride 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 28 0409-0125-25 Labetalol Hydrochloride 25 in 1 TRAY INJECTION, SOLUTION 25 28
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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0125 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 25 Current NDC, 2 package rows 20241210_abfc6b75-1ed5-41f1-0484-4597488237bc.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 Units Marketing start Sample Exclude flag Status 0409-0125-01 00409012501 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 0409-0125-25 00409012525 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) 2023-08-07 No No Current