labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler cardinal health 107, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4747
Product ID 55154-4747_ae113f45-ad3e-4bd8-9119-b68d305b9af9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075239
Listing Expiration 2026-12-31
Marketing Start 1999-11-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551544747
Hyphenated Format 55154-4747

Supplemental Identifiers

RxCUI
1234256
UPC
0055154474757
UNII
1GEV3BAW9J

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
  • 5 CARTRIDGE in 1 BAG (55154-4747-5) / 4 mL in 1 CARTRIDGE
source: ndc

Packages (1)

55154-4747-5 5 CARTRIDGE in 1 BAG (55154-4747-5) / 4 mL in 1 CARTRIDGE

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": "ae113f45-ad3e-4bd8-9119-b68d305b9af9", "openfda": {"upc": ["0055154474757"], "unii": ["1GEV3BAW9J"], "rxcui": ["1234256"], "spl_set_id": ["1b96ddc9-d0c3-488a-a113-66491fd3d899"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTRIDGE in 1 BAG (55154-4747-5)  / 4 mL in 1 CARTRIDGE", "package_ndc": "55154-4747-5", "marketing_start_date": "19991129"}], "brand_name": "Labetalol Hydrochloride", "product_id": "55154-4747_ae113f45-ad3e-4bd8-9119-b68d305b9af9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "55154-4747", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "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": "19991129", "listing_expiration_date": "20261231"}