Package 68083-111-02
Brand: labetalol hydrochloride
Generic: labetalol hydrochloridePackage Facts
Identity
Package NDC
68083-111-02
Digits Only
6808311102
Product NDC
68083-111
Description
10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
labetalol hydrochloride
Generic
labetalol hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "f3cca933-34c3-4efd-81c6-02a4920dda16", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["48caf986-3126-48e1-afcd-16d65c9cfe00"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS", "package_ndc": "68083-111-01", "marketing_start_date": "20120419"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS", "package_ndc": "68083-111-02", "marketing_start_date": "20120419"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-111", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090699", "marketing_category": "ANDA", "marketing_start_date": "20120419", "listing_expiration_date": "20261231"}