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 300 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-468
Product ID 72888-468_35a89027-9232-dad9-e063-6394a90a7787
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211953
Listing Expiration 2026-12-31
Marketing Start 2025-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888468
Hyphenated Format 72888-468

Supplemental Identifiers

RxCUI
896766
UPC
0372888468020 0372888468013
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
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02)
source: ndc

Packages (2)

72888-468-01 500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01) 72888-468-02 100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02)

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": "35a89027-9232-dad9-e063-6394a90a7787", "openfda": {"upc": ["0372888468020", "0372888468013"], "unii": ["1GEV3BAW9J"], "rxcui": ["896766"], "spl_set_id": ["106a0959-5830-489f-ba60-afd4eb0fac36"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01)", "package_ndc": "72888-468-01", "marketing_start_date": "20250520"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02)", "package_ndc": "72888-468-02", "marketing_start_date": "20250520"}], "brand_name": "LABETALOL HYDROCHLORIDE", "product_id": "72888-468_35a89027-9232-dad9-e063-6394a90a7787", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72888-468", "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": "300 mg/1"}], "application_number": "ANDA211953", "marketing_category": "ANDA", "marketing_start_date": "20250520", "listing_expiration_date": "20261231"}