labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-2339
Product ID 0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075239
Listing Expiration 2026-12-31
Marketing Start 2005-10-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04092339
Hyphenated Format 0409-2339

Supplemental Identifiers

RxCUI
1234256
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 ANDA075239 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 PACKAGE (0409-2339-34) / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24)
source: ndc

Packages (1)

0409-2339-34 10 CARTON in 1 PACKAGE (0409-2339-34) / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24)

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": "7ba44762-b760-4a8f-adce-65bf78cc5d98", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["1234256"], "spl_set_id": ["d3579d45-a964-40fe-e3a2-a3a997c8b7b9"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 PACKAGE (0409-2339-34)  / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24)", "package_ndc": "0409-2339-34", "marketing_start_date": "20051018"}], "brand_name": "Labetalol Hydrochloride", "product_id": "0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0409-2339", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075239", "marketing_category": "ANDA", "marketing_start_date": "20051018", "listing_expiration_date": "20261231"}