labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6741
Product ID 50090-6741_bee54e03-a973-47f7-b726-5d7f6d3bf61e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211953
Listing Expiration 2026-12-31
Marketing Start 2021-08-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906741
Hyphenated Format 50090-6741

Supplemental Identifiers

RxCUI
896758
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 ANDA211953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-6741-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-6741-1)
source: ndc

Packages (2)

50090-6741-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-6741-0) 50090-6741-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-6741-1)

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": "bee54e03-a973-47f7-b726-5d7f6d3bf61e", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758"], "spl_set_id": ["c586ab65-56e8-4a4f-b471-902198d3e58c"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-6741-0)", "package_ndc": "50090-6741-0", "marketing_start_date": "20231013"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6741-1)", "package_ndc": "50090-6741-1", "marketing_start_date": "20231013"}], "brand_name": "LABETALOL HYDROCHLORIDE", "product_id": "50090-6741_bee54e03-a973-47f7-b726-5d7f6d3bf61e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-6741", "generic_name": "Labetalol Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LABETALOL HYDROCHLORIDE", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA211953", "marketing_category": "ANDA", "marketing_start_date": "20210818", "listing_expiration_date": "20261231"}