labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-095
Product ID 71205-095_5179866d-f336-4e03-85b0-972fbedb6b9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075133
Listing Expiration 2026-12-31
Marketing Start 1998-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205095
Hyphenated Format 71205-095

Supplemental Identifiers

RxCUI
896758
UPC
0371205095901
UNII
1GEV3BAW9J

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
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90)
source: ndc

Packages (3)

71205-095-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30) 71205-095-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60) 71205-095-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90)

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": "5179866d-f336-4e03-85b0-972fbedb6b9e", "openfda": {"upc": ["0371205095901"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758"], "spl_set_id": ["c0301841-e209-4242-bace-58a20e6dd01b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30)", "package_ndc": "71205-095-30", "marketing_start_date": "20180801"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60)", "package_ndc": "71205-095-60", "marketing_start_date": "20180801"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90)", "package_ndc": "71205-095-90", "marketing_start_date": "20180801"}], "brand_name": "Labetalol hydrochloride", "product_id": "71205-095_5179866d-f336-4e03-85b0-972fbedb6b9e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71205-095", "generic_name": "Labetalol hydrochloride", "labeler_name": "Proficient Rx LP", "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_start_date": "19980803", "listing_expiration_date": "20261231"}