Home NDC 36000-320 Labetalol Hydrochloride
Product NDC 36000-320
11-digit product format 360000320
Labeler code 36000
Product ID 36000-320_219d4dec-02d1-4d4b-88fd-01b1dbad3abc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA076051
Marketing category ANDA
Marketing start 2021-01-26
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 A076051-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076051-001 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 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 2002-07-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076051-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2002-07-05 e64feba35796…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896771 Internal RxNorm lookup 2477889 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 36000-320-01 Labetalol Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 6 36000-320-10 Labetalol Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-320 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 5 Current NDC, Legacy NDC, 2 package rows 20240921_b17a7b3a-e7a5-4987-ae85-ad970e7540c7.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 Marketing end Sample Exclude flag Status 36000-320-01 36000032001 4 mL in 1 VIAL 4 ml Historical 36000-320-10 36000032010 10 VIAL in 1 CARTON (36000-320-10) / 4 mL in 1 VIAL (36000-320-01) 10 vial 2021-01-26 0000-00-00 No No Current