Package 83301-0059-1

Brand: labetalol hydrochloride

Generic: labetalol hydrochloride
NDC Package

Package Facts

Identity

Package NDC 83301-0059-1
Digits Only 8330100591
Product NDC 83301-0059
Product ID 83301-0059_e49bc25a-e39e-469a-8372-bd28e2b1ca7f
Description

1 VIAL, MULTI-DOSE in 1 CARTON (83301-0059-1) / 40 mL in 1 VIAL, MULTI-DOSE

Marketing

Marketing Status
Marketed Since 2025-12-05
Brand labetalol hydrochloride
Generic labetalol hydrochloride
Sample Package No

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e49bc25a-e39e-469a-8372-bd28e2b1ca7f", "openfda": {"upc": ["0383301005814"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["fb5ef3ba-0a7e-4f41-9547-d734983da0d3"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (83301-0059-1)  / 40 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "83301-0059-1", "marketing_start_date": "20251205"}], "brand_name": "Labetalol Hydrochloride", "product_id": "83301-0059_e49bc25a-e39e-469a-8372-bd28e2b1ca7f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "83301-0059", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/40mL"}], "application_number": "ANDA090699", "marketing_category": "ANDA", "marketing_start_date": "20251205", "listing_expiration_date": "20261231"}