labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-515
Product ID 33342-515_366134cd-6244-45fc-99f1-0193a0221b3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217949
Listing Expiration 2026-12-31
Marketing Start 2025-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342515
Hyphenated Format 33342-515

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0333342516114 0333342515155 0333342517111
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 ANDA217949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-515-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-515-15)
source: ndc

Packages (2)

33342-515-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-515-11) 33342-515-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-515-15)

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": "366134cd-6244-45fc-99f1-0193a0221b3a", "openfda": {"upc": ["0333342516114", "0333342515155", "0333342517111"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["366134cd-6244-45fc-99f1-0193a0221b3a"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-515-11)", "package_ndc": "33342-515-11", "marketing_start_date": "20250923"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-515-15)", "package_ndc": "33342-515-15", "marketing_start_date": "20250923"}], "brand_name": "Labetalol Hydrochloride", "product_id": "33342-515_366134cd-6244-45fc-99f1-0193a0221b3a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "33342-515", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA217949", "marketing_category": "ANDA", "marketing_start_date": "20250923", "listing_expiration_date": "20261231"}