Home NDC 25021-317 labetalol hydrochloride
Product NDC 25021-317
11-digit product format 250210317
Labeler code 25021
Product ID 25021-317_02cc0ab9-5ab4-4016-9ec2-b96c4cb2be41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name labetalol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA214533
Marketing category ANDA
Marketing start 2022-09-01
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 A214533-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214533-001 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.
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 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214533-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2021-09-07 a50c72e98297…
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 · 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 25021-317-20 labetalol hydrochloride 20 mL in 1 VIAL INJECTION, SOLUTION 20 4 25021-317-20 labetalol hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 4 25021-317-40 labetalol hydrochloride 40 mL in 1 VIAL INJECTION, SOLUTION 40 4 25021-317-40 labetalol hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-317 LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 4 package rows 20221116_da8af6c2-d822-4ae5-9c2d-a1d161bdefd0.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 · 3 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 25021-317-20 25021031720 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL 1 vial 2022-09-01 0000-00-00 No No Current 25021-317-40 25021031740 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL 1 vial 2022-09-01 0000-00-00 No No Current