Atovaquone and Proguanil Hydrochloride

Product NDC
68462-404
11-digit product format
684620404
Labeler code
68462
Product ID
68462-404_a6232b89-d1c0-4114-879d-6c9320a92eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone and Proguanil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc.,USA
Application
ANDA091211
Marketing category
ANDA
Marketing start
2011-09-15
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68462-40468462-404-10DDiscontinued by firm2026-09-14
excluded packagepackage68462-40468462-404-60DDiscontinued by firm2026-09-14
excluded packagepackage68462-40468462-404-90DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0568462-404-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568462-404-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568462-404-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2668462-404-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668462-404-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668462-404-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3168462-404-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168462-404-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168462-404-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2868462-404-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868462-404-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868462-404-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2168462-404-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168462-404-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168462-404-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1068462-404-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068462-404-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068462-404-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3168462-404-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168462-404-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168462-404-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2068462-404-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068462-404-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068462-404-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1068462-404-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068462-404-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068462-404-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0868462-404-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868462-404-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868462-404-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0368462-404-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368462-404-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368462-404-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0968462-404-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968462-404-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968462-404-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12
A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091211-001AB
A091211-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1284e616aacf4f…
2026-09-14 22:38:342026-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12caaa826d4ba7…
2026-08-18 06:07:402026-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091211-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091211-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A091211-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091211-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091211-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091211-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091211-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091211-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091211-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002AB174a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone and Proguanil Hydrochloride
Listing expiration
2027-12-31

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
R71Y86M0WTInternal UNII lookup
Y883P1Z2LTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864675Internal RxNorm lookup
864681Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b80d087-eaa7-448f-967e-344de7f16436Available 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
68462-404-01Atovaquone and Proguanil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10014
68462-404-10Atovaquone and Proguanil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100014
68462-404-44Atovaquone and Proguanil Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED1214
68462-404-60Atovaquone and Proguanil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6014
68462-404-67Atovaquone and Proguanil Hydrochloride2 in 1 CARTONTABLET, FILM COATED214
68462-404-90Atovaquone and Proguanil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-404-01EA - Each68462-4047aebf8d2-18ce-4940-9ef0-b792627544c712012-07-24
68462-404-44EA - Each68462-4045c44903b-55a9-4fb3-87f1-76aa833e35d012026-02-05
68462-404-67EA - Each68462-404a25082e5-f5e0-4dc7-a274-51d076af0b6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]7
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-404ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]12Current NDC, Legacy NDC, 6 package rows20230111_4b80d087-eaa7-448f-967e-344de7f16436.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBryant Ranch Prepacke4ff57f7-07af-4872-ac3a-c521e098ccfe2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil Hydrochloride PediatricATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRICGlenmark Pharmaceuticals Inc.,USA4b80d087-eaa7-448f-967e-344de7f164362026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
ndc (product): 68462-404
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEProficient Rx LPe74b00fc-8743-4e9d-8a83-aab8e531b3ba2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN4b80d087-eaa7-448f-967e-344de7f1643614
864681atovaquone 62.5 MG / proguanil HCl 25 MG Oral TabletPSN4b80d087-eaa7-448f-967e-344de7f1643614
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD4b80d087-eaa7-448f-967e-344de7f1643614
864681atovaquone 62.5 MG / proguanil hydrochloride 25 MG Oral TabletSCD4b80d087-eaa7-448f-967e-344de7f1643614
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSNe74b00fc-8743-4e9d-8a83-aab8e531b3ba6
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCDe74b00fc-8743-4e9d-8a83-aab8e531b3ba6
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSNf8659107-ef6b-4142-a4b8-6934aae07f411
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN01cb577f-c355-b88f-e063-6394a90af9ce1
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN03b1a85e-16ff-7cec-e063-6394a90a98dc1
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN13eef6e5-4534-3009-e054-00144ff8d46c1
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN186ad795-f19a-4df6-8f81-b2028a3da2291
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSNc50d51ab-23c2-45cb-8f68-08f3454fb59b1
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCDf8659107-ef6b-4142-a4b8-6934aae07f411
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCDc50d51ab-23c2-45cb-8f68-08f3454fb59b1
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD186ad795-f19a-4df6-8f81-b2028a3da2291
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD13eef6e5-4534-3009-e054-00144ff8d46c1
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD03b1a85e-16ff-7cec-e063-6394a90a98dc1
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD01cb577f-c355-b88f-e063-6394a90af9ce1
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-404-0168462040401100 TABLET, FILM COATED in 1 BOTTLE (68462-404-01) 2011-09-150000-00-00NoNoCurrent
68462-404-10684620404101000 in 1 BOTTLEHistorical
68462-404-446846204044412 in 1 BLISTER PACKHistorical
68462-404-606846204046060 in 1 BOTTLEHistorical
68462-404-67684620404672 BLISTER PACK in 1 CARTON (68462-404-67) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44) 2 blister pack2011-09-150000-00-00NoNoCurrent
68462-404-906846204049090 in 1 BOTTLEHistorical