Package 0378-4162-01

Brand: atovaquone and proguanil hydrochloride

Generic: atovaquone and proguanil hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0378-4162-01
Digits Only 0378416201
Product NDC 0378-4162
Description

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01)

Marketing

Marketing Status
Marketed Since 2014-05-28
Brand atovaquone and proguanil hydrochloride
Generic atovaquone and proguanil hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "bcbdccd4-74df-4499-9d98-2e95c958c7f6", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0303784162019", "0303784160015"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675", "864681"], "spl_set_id": ["57d74d71-8cf8-4b10-9420-22954fae623c"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01)", "package_ndc": "0378-4162-01", "marketing_start_date": "20140528"}], "brand_name": "Atovaquone and Proguanil Hydrochloride", "product_id": "0378-4162_bcbdccd4-74df-4499-9d98-2e95c958c7f6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "0378-4162", "generic_name": "atovaquone and proguanil hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone and Proguanil Hydrochloride", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "250 mg/1"}, {"name": "PROGUANIL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA202362", "marketing_category": "ANDA", "marketing_start_date": "20140528", "listing_expiration_date": "20261231"}