Home NDC 70121-2428-3 LABETALOL HYDROCHLORIDE
Product NDC 70121-2428
Requested package NDC 70121-2428-3
11-digit product format 701212428
Labeler code 70121
Product ID 70121-2428_1878c304-0b8f-402d-8dd1-7d6be6108d07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name labetalol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA218870
Marketing category ANDA
Marketing start 2025-10-02
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 44 .
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 A218870-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218870-001 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 2026-10-15 13:18:30 2026-09 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218870-001 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2025-10-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 2727439 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 70121-2428-1 LABETALOL HYDROCHLORIDE 4 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 4 7 70121-2428-1 LABETALOL HYDROCHLORIDE 1 in 1 CARTON INJECTION, SOLUTION 1 7 70121-2428-3 LABETALOL HYDROCHLORIDE 24 in 1 CARTON INJECTION, SOLUTION 24 7
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 70121-2428-3 70121242803 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASS 24 carton 2025-10-02 No No Current