labetalol hcl in sodium chloride

Generic: labetalol hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hcl in sodium chloride
Generic Name labetalol hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9365
Product ID 0143-9365_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213330
Listing Expiration 2026-12-31
Marketing Start 2020-11-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439365
Hyphenated Format 0143-9365

Supplemental Identifiers

RxCUI
2477889 2479564 2479566 2479567
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 hcl in sodium chloride (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number NDA213330 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01)
source: ndc

Packages (1)

0143-9365-10 10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01)

Ingredients (1)

labetalol hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Labetalol Hydrochloride, Labetalol HCl in Sodium Chloride, Labetalol HCl in Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["2477889", "2479564", "2479566", "2479567"], "spl_set_id": ["99a715a0-4579-410c-b102-7ef6fab8db55"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 BOX (0143-9365-10)  / 300 mL in 1 BAG (0143-9365-01)", "package_ndc": "0143-9365-10", "marketing_start_date": "20201109"}], "brand_name": "Labetalol HCl in Sodium Chloride", "product_id": "0143-9365_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0143-9365", "generic_name": "LABETALOL HYDROCHLORIDE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol HCl in Sodium Chloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA213330", "marketing_category": "NDA", "marketing_start_date": "20201109", "listing_expiration_date": "20261231"}