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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-0184
Product ID 55154-0184_6054fdc7-f467-40f7-9ffe-92e20736ffbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2027-12-31
Marketing Start 2025-05-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551540184
Hyphenated Format 55154-0184

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0055154018104 0055154018401 0055154018203
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 ANDA209603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-0184-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-0184-0 10 BLISTER PACK in 1 BAG (55154-0184-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

labetalol hydrochloride (300 mg/1)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6054fdc7-f467-40f7-9ffe-92e20736ffbf", "openfda": {"upc": ["0055154018104", "0055154018401", "0055154018203"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["d3ca153c-25b2-4506-91bd-bf9d6a4c01fe"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-0184-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-0184-0", "marketing_start_date": "20250506"}], "brand_name": "Labetalol Hydrochloride", "product_id": "55154-0184_6054fdc7-f467-40f7-9ffe-92e20736ffbf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "55154-0184", "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": "300 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20250506", "listing_expiration_date": "20271231"}