Home NDC 83270-178 LABETALOL HYDROCHLORIDE
Product NDC 83270-178
11-digit product format 832700178
Labeler code 83270
Product ID 83270-178_556364b1-527d-bd9c-e063-6394a90aee8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LABETALOL HYDROCHLORIDE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Onesource Specialty Pharma Limited
Application ANDA079134
Marketing category ANDA
Marketing start 2026-02-27
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079134-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03
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 · 43 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 2026-09-14 22:38:34 2026-08 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2010-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2010-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079134-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2010-02-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A079134-001 AP 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079134-001 AP 1 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83270-178-01 83270017801 1 VIAL, MULTI-DOSE in 1 CARTON (83270-178-01) / 20 mL in 1 VIAL, MULTI-DOSE 2026-02-27 No No Current