atovaquone and proguanil hydrochloride (0378-4162)

Drug Facts

Product Profile

Brand Name atovaquone and proguanil hydrochloride

Generic Name atovaquone and proguanil hydrochloride

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

atovaquone 250 mg/1, proguanil hydrochloride 100 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4162

Product ID 0378-4162_bcbdccd4-74df-4499-9d98-2e95c958c7f6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202362

Listing Expiration 2026-12-31

Marketing Start 2014-05-28

Pharmacologic Class

Established (EPC)

antimalarial [epc] antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784162

Hyphenated Format 0378-4162

Supplemental Identifiers

RxCUI

864675 864681

UPC

0303784162019 0303784160015

UNII

Y883P1Z2LT R71Y86M0WT

NUI

N0000175482 N0000175485

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name atovaquone and proguanil hydrochloride (source: ndc)

Generic Name atovaquone and proguanil hydrochloride (source: ndc)

Application Number ANDA202362 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
100 mg/1

source: ndc

Packaging

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

source: ndc

Packages (1)

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

Ingredients (2)

atovaquone (250 mg/1) proguanil hydrochloride (100 mg/1)

Linked Drug Pages (1)

Atovaquone and Proguanil Hydrochloride ndc-match (0.9)

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"}