Package 68382-640-16

Brand: dutasteride and tamsulosin hydrochloride

Generic: dutasteride and tamsulosin hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68382-640-16
Digits Only 6838264016
Product NDC 68382-640
Description

90 CAPSULE in 1 BOTTLE (68382-640-16)

Marketing

Marketing Status
Marketed Since 2018-06-04
Brand dutasteride and tamsulosin hydrochloride
Generic dutasteride and tamsulosin hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "9e44a416-1d3d-418c-a113-f6c65175b564", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I", "11SV1951MR"], "rxcui": ["996097"], "spl_set_id": ["d6557691-7910-4006-9268-410583e437d1"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-640-06)", "package_ndc": "68382-640-06", "marketing_start_date": "20180604"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-640-16)", "package_ndc": "68382-640-16", "marketing_start_date": "20180604"}], "brand_name": "Dutasteride and tamsulosin hydrochloride", "product_id": "68382-640_9e44a416-1d3d-418c-a113-f6c65175b564", "dosage_form": "CAPSULE", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]", "Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "68382-640", "generic_name": "Dutasteride and tamsulosin hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride and tamsulosin hydrochloride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}, {"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA207769", "marketing_category": "ANDA", "marketing_start_date": "20180604", "listing_expiration_date": "20261231"}