labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler advagen pharma ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 200 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-121
Product ID 72888-121_473c8757-9bbe-0aa1-e063-6394a90af1ee
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 72888121
Hyphenated Format 72888-121

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0372888120010 0372888120058 0372888121055 0372888122014 0372888122052 0372888121017
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 ANDA211953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-121-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72888-121-05)
source: ndc

Packages (2)

72888-121-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-121-01) 72888-121-05 500 TABLET, FILM COATED in 1 BOTTLE (72888-121-05)

Ingredients (1)

labetalol hydrochloride (200 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": "473c8757-9bbe-0aa1-e063-6394a90af1ee", "openfda": {"upc": ["0372888120010", "0372888120058", "0372888121055", "0372888122014", "0372888122052", "0372888121017"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["1c680447-b43a-4ff1-bc64-2c2174ca1c9a"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-121-01)", "package_ndc": "72888-121-01", "marketing_start_date": "20210818"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72888-121-05)", "package_ndc": "72888-121-05", "marketing_start_date": "20210818"}], "brand_name": "LABETALOL HYDROCHLORIDE", "product_id": "72888-121_473c8757-9bbe-0aa1-e063-6394a90af1ee", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72888-121", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LABETALOL HYDROCHLORIDE", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA211953", "marketing_category": "ANDA", "marketing_start_date": "20210818", "listing_expiration_date": "20261231"}