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 100 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8192
Product ID 55154-8192_9be82c15-a0ba-4f52-8e76-6700731db35e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207743
Listing Expiration 2026-12-31
Marketing Start 2019-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551548192
Hyphenated Format 55154-8192

Supplemental Identifiers

RxCUI
896758 896762
UPC
0055154214308 0055154819206
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 ANDA207743 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-8192-0 10 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

labetalol hydrochloride (100 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": "9be82c15-a0ba-4f52-8e76-6700731db35e", "openfda": {"upc": ["0055154214308", "0055154819206"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762"], "spl_set_id": ["63db5b00-e864-4b2d-84f2-00bf35211b9b"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-8192-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-8192-0", "marketing_start_date": "20190716"}], "brand_name": "Labetalol Hydrochloride", "product_id": "55154-8192_9be82c15-a0ba-4f52-8e76-6700731db35e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "55154-8192", "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": "100 mg/1"}], "application_number": "ANDA207743", "marketing_category": "ANDA", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}