labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2428
Product ID 70121-2428_1878c304-0b8f-402d-8dd1-7d6be6108d07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218870
Listing Expiration 2026-12-31
Marketing Start 2025-10-02

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701212428
Hyphenated Format 70121-2428

Supplemental Identifiers

RxCUI
2727439
UNII
1GEV3BAW9J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name labetalol hydrochloride (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA218870 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

70121-2428-3 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASS

Ingredients (1)

labetalol hydrochloride (5 mg/mL)

Linked Drug Pages (1)

LABETALOL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1878c304-0b8f-402d-8dd1-7d6be6108d07", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["2727439"], "spl_set_id": ["dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 CARTON in 1 CARTON (70121-2428-3)  / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1)  / 4 mL in 1 SYRINGE, GLASS", "package_ndc": "70121-2428-3", "marketing_start_date": "20251002"}], "brand_name": "LABETALOL HYDROCHLORIDE", "product_id": "70121-2428_1878c304-0b8f-402d-8dd1-7d6be6108d07", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70121-2428", "generic_name": "labetalol hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LABETALOL HYDROCHLORIDE", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA218870", "marketing_category": "ANDA", "marketing_start_date": "20251002", "listing_expiration_date": "20261231"}