labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0605
Product ID 0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075133
Marketing Start 1998-08-03
Marketing End 2026-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910605
Hyphenated Format 0591-0605

Supplemental Identifiers

RxCUI
896758 896762 896766
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 ANDA075133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05)
source: ndc

Packages (2)

0591-0605-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01) 0591-0605-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05)

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": "d5dfcb69-d2c4-49ca-a684-83c9e15b3b06", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["a5b65a9b-6b8a-48a4-9c72-0e605bb309eb"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01)", "package_ndc": "0591-0605-01", "marketing_end_date": "20260930", "marketing_start_date": "19980803"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05)", "package_ndc": "0591-0605-05", "marketing_end_date": "20260930", "marketing_start_date": "19980803"}], "brand_name": "Labetalol hydrochloride", "product_id": "0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0591-0605", "generic_name": "Labetalol hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA075133", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "19980803"}