Package 68382-799-16
Brand: labetalol hydrochloride
Generic: labetalol hydrochloridePackage Facts
Identity
Package NDC
68382-799-16
Digits Only
6838279916
Product NDC
68382-799
Description
90 TABLET, FILM COATED in 1 BOTTLE (68382-799-16)
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": ["ORAL"], "spl_id": "f4b4d2f0-55ad-4eda-a128-5f0c21dbe86b", "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 (68382-799-01)", "package_ndc": "68382-799-01", "marketing_start_date": "20171205"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-799-05)", "package_ndc": "68382-799-05", "marketing_start_date": "20171205"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-799-06)", "package_ndc": "68382-799-06", "marketing_start_date": "20171205"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-799-16)", "package_ndc": "68382-799-16", "marketing_start_date": "20171205"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68382-799_f4b4d2f0-55ad-4eda-a128-5f0c21dbe86b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68382-799", "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": "200 mg/1"}], "application_number": "ANDA207743", "marketing_category": "ANDA", "marketing_start_date": "20171205", "listing_expiration_date": "20261231"}