labetalol hydrochloride

Generic: labetalol

Labeler: marlex pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

labetalol 100 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-711
Product ID 10135-711_23e98950-6176-fa93-e063-6294a90a60a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075215
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

Pharmacologic Class

Established (EPC)
beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic beta-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135711
Hyphenated Format 10135-711

Supplemental Identifiers

RxCUI
896758 896762 896766
UNII
R5H8897N95
NUI
N0000000161 N0000175556

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 (source: ndc)
Application Number ANDA075215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (10135-711-05)
source: ndc

Packages (2)

10135-711-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01) 10135-711-05 500 TABLET, FILM COATED in 1 BOTTLE (10135-711-05)

Ingredients (1)

labetalol (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": "23e98950-6176-fa93-e063-6294a90a60a9", "openfda": {"nui": ["N0000000161", "N0000175556"], "unii": ["R5H8897N95"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["28c91727-e5a8-48b3-a4df-d7bec8feda40"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01)", "package_ndc": "10135-711-01", "marketing_start_date": "20201001"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (10135-711-05)", "package_ndc": "10135-711-05", "marketing_start_date": "20201001"}], "brand_name": "Labetalol Hydrochloride", "product_id": "10135-711_23e98950-6176-fa93-e063-6294a90a60a9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "10135-711", "generic_name": "Labetalol", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL", "strength": "100 mg/1"}], "application_number": "ANDA075215", "marketing_category": "ANDA", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}