atovaquone and proguanil hydrochloride

Generic: atovaquone and proguanil hydrochloride

Labeler: glenmark pharmaceuticals inc.,usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone and proguanil hydrochloride
Generic Name atovaquone and proguanil hydrochloride
Labeler glenmark pharmaceuticals inc.,usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Glenmark Pharmaceuticals Inc.,USA

Identifiers & Regulatory

Product NDC 68462-404
Product ID 68462-404_35216261-40cc-4bcc-b2ce-4d027e1d7b71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091211
Listing Expiration 2027-12-31
Marketing Start 2011-09-15

Pharmacologic Class

Established (EPC)
antimalarial [epc] antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462404
Hyphenated Format 68462-404

Supplemental Identifiers

RxCUI
864675 864681
UPC
0368462402016 0368462404010
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 ANDA091211 (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 (68462-404-01)
  • 2 BLISTER PACK in 1 CARTON (68462-404-67) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44)
source: ndc

Packages (2)

68462-404-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-404-01) 68462-404-67 2 BLISTER PACK in 1 CARTON (68462-404-67) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44)

Ingredients (2)

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

Linked Drug Pages (1)

Atovaquone and Proguanil Hydrochloride Pediatric, Atovaquone and Proguanil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35216261-40cc-4bcc-b2ce-4d027e1d7b71", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0368462402016", "0368462404010"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675", "864681"], "spl_set_id": ["4b80d087-eaa7-448f-967e-344de7f16436"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc.,USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-404-01)", "package_ndc": "68462-404-01", "marketing_start_date": "20110915"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68462-404-67)  / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44)", "package_ndc": "68462-404-67", "marketing_start_date": "20110915"}], "brand_name": "Atovaquone and Proguanil Hydrochloride", "product_id": "68462-404_35216261-40cc-4bcc-b2ce-4d027e1d7b71", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "68462-404", "generic_name": "Atovaquone and Proguanil Hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc.,USA", "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": "ANDA091211", "marketing_category": "ANDA", "marketing_start_date": "20110915", "listing_expiration_date": "20271231"}