Atovaquone and Proguanil HCl

Product NDC
66993-060
11-digit product format
669930060
Labeler code
66993
Product ID
66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-27
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250; 100 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021078-001MALARONEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALABRLD, RS2000-07-14
N021078-002MALARONE PEDIATRICATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALABRLD2000-07-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021078-001AB
N021078-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021078-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021078-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021078-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021078-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021078-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021078-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021078-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021078-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021078-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021078-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021078-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021078-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021078-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021078-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021078-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021078-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021078-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021078-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone and Proguanil HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE250 mg/1
PROGUANIL HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y883P1Z2LTInternal UNII lookup
R71Y86M0WTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864675Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7069521a-c7f9-4e8d-99b8-0cb5c971e7cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-060-02Atovaquone and Proguanil HCl100 in 1 BOTTLETABLET, FILM COATED10015
66993-060-27Atovaquone and Proguanil HCl24 in 1 DOSE PACKTABLET, FILM COATED2415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-060-02EA - Each66993-060b2821934-b008-4e92-9aca-88fdf75abfe112013-02-13
66993-060-27EA - Each66993-0608ee2fbff-608a-4137-8509-01bf9172b9a112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-060ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]14Current NDC, Legacy NDC, 2 package rows20240901_7069521a-c7f9-4e8d-99b8-0cb5c971e7cf.zip

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MALARONEATOVAQUONE AND PROGUANIL HYDROCHLORIDEGlaxoSmithKline LLCfc22e8d8-3bfb-4f70-a599-dd81262a48872026-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEA-S Medication Solutions593baf3d-bd9e-4a44-8f90-125aa4a7a99e2023-10-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrasco Laboratories7069521a-c7f9-4e8d-99b8-0cb5c971e7cf2022-05-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
ndc (product): 66993-060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN593baf3d-bd9e-4a44-8f90-125aa4a7a99e16
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD593baf3d-bd9e-4a44-8f90-125aa4a7a99e16
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN7069521a-c7f9-4e8d-99b8-0cb5c971e7cf15
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD7069521a-c7f9-4e8d-99b8-0cb5c971e7cf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-060-0266993006002100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02) 2012-07-270000-00-00NoNoCurrent
66993-060-276699300602724 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27) 2012-07-270000-00-00NoNoCurrent