Package 68382-798-05

Brand: labetalol hydrochloride

Generic: labetalol hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68382-798-05
Digits Only 6838279805
Product NDC 68382-798
Description

500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05)

Marketing

Marketing Status
Marketed Since 2017-12-05
Brand labetalol hydrochloride
Generic labetalol hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "49639538-dfdd-4312-9664-701e8bdbe191", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["5942a5a8-c3c1-4ecb-921e-9bc92393bdf8"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01)", "package_ndc": "68382-798-01", "marketing_start_date": "20171205"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05)", "package_ndc": "68382-798-05", "marketing_start_date": "20171205"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-798-06)", "package_ndc": "68382-798-06", "marketing_start_date": "20171205"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-798-16)", "package_ndc": "68382-798-16", "marketing_start_date": "20171205"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68382-798_49639538-dfdd-4312-9664-701e8bdbe191", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68382-798", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA207743", "marketing_category": "ANDA", "marketing_start_date": "20171205", "listing_expiration_date": "20271231"}