FDA.reportPublic FDA data

NDC 68001-245-14 - Atovaquone and Proguanil Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68001-245
Requested NDC
68001-245-14
Package NDCs from labels
68001-245-00, 68001-245-14, 68001-245-15
Manufacturer
BluePoint Laboratories | Glenmark Pharmaceuticals Limited
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ATOVAQUONE - BluePoint Laboratories | Glenmark Pharmaceuticals LimitedBluePoint Laboratories | Glenmark Pharmaceuticals Limited2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-245-00Atovaquone and Proguanil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
68001-245-14Atovaquone and Proguanil Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED128
68001-245-15Atovaquone and Proguanil Hydrochloride2 in 1 CARTONTABLET, FILM COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-245ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 3 package rows20221217_ad25ab65-42aa-48f6-b5ed-247f3685d5bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-245-00EA - Each68001-24596087467-69e2-40dc-91e5-4902de9fed6b12014-05-02
68001-245-14EA - Each68001-2455f5555da-499a-4c9b-8fe6-fccd9e112dc712014-05-02
68001-245-15EA - Each68001-245639c30f6-ff84-4f24-b95e-da1dfc453a6b12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 142 · 2,825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA091211
ndc (package): 68001-245-14
ndc (package): 68001-245-00
ndc (package): 68001-245-15
ndc (product): 68001-245
ndc11 (package): 68001024514
rxcui: 864675
spl id: 5a928626-0b3c-9a9b-e063-6394a90a6adc
spl set id: ad25ab65-42aa-48f6-b5ed-247f3685d5bf
unii: R71Y86M0WT
unii: Y883P1Z2LT
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.