labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-327
Product ID 42806-327_b950655d-a9f8-4ace-bb56-0c7abbca231e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212990
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806327
Hyphenated Format 42806-327

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0342806327012
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 ANDA212990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-327-01)
  • 500 TABLET in 1 BOTTLE (42806-327-05)
  • 1000 TABLET in 1 BOTTLE (42806-327-10)
source: ndc

Packages (3)

42806-327-01 100 TABLET in 1 BOTTLE (42806-327-01) 42806-327-05 500 TABLET in 1 BOTTLE (42806-327-05) 42806-327-10 1000 TABLET in 1 BOTTLE (42806-327-10)

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": "b950655d-a9f8-4ace-bb56-0c7abbca231e", "openfda": {"upc": ["0342806327012"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["b950655d-a9f8-4ace-bb56-0c7abbca231e"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-327-01)", "package_ndc": "42806-327-01", "marketing_start_date": "20210930"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42806-327-05)", "package_ndc": "42806-327-05", "marketing_start_date": "20210930"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42806-327-10)", "package_ndc": "42806-327-10", "marketing_start_date": "20210930"}], "brand_name": "Labetalol Hydrochloride", "product_id": "42806-327_b950655d-a9f8-4ace-bb56-0c7abbca231e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42806-327", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA212990", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}