Atovaquone and Proguanil Hydrochloride

Product NDC: 0378-4162
11-digit product format: 003784162
Labeler code: 0378
Product ID: 0378-4162_bf8ac578-e07c-44b0-bc85-47919e3a848c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atovaquone and proguanil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA202362
Marketing category: ANDA
Marketing start: 2014-05-28
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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB		2014-05-27
A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB		2014-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202362-001	AB
A202362-002	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202362-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202362-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202362-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202362-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202362-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202362-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202362-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202362-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202362-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202362-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202362-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202362-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202362-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202362-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202362-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202362-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202362-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202362-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202362-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202362-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202362-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202362-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202362-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202362-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202362-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202362-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202362-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202362-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202362-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202362-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202362-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202362-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202362-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202362-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202362-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202362-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202362-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202362-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202362-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202362-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATOVAQUONE	250 mg/1
PROGUANIL HYDROCHLORIDE	100 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9	Product name	8	20220517
7beb5026-9819-5e26-fae7-eca2788430de	Product name	2	20150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-4162-01	Atovaquone and Proguanil Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4162-01	EA - Each	0378-4162	fd8851aa-c7e6-4b6d-8343-53ea826b6310	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4162	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 1 package rows	20240726_57d74d71-8cf8-4b10-9420-22954fae623c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	152433eb-1341-9cc0-e063-6394a90a1481	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202362 application number: ANDA202362

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y883P1Z2LT	ATOVAQUONE	95233-18-4	ATOVAQUONE
R71Y86M0WT	PROGUANIL HYDROCHLORIDE	637-32-1	PROGUANIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	57d74d71-8cf8-4b10-9420-22954fae623c	9
864681	atovaquone 62.5 MG / proguanil HCl 25 MG Oral Tablet	PSN	57d74d71-8cf8-4b10-9420-22954fae623c	9
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	57d74d71-8cf8-4b10-9420-22954fae623c	9
864681	atovaquone 62.5 MG / proguanil hydrochloride 25 MG Oral Tablet	SCD	57d74d71-8cf8-4b10-9420-22954fae623c	9
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	152433eb-1341-9cc0-e063-6394a90a1481	2
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	152433eb-1341-9cc0-e063-6394a90a1481	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4162-01	00378416201	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01)	2014-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	Mylan Pharmaceuticals Inc.	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	10
Atovaquone and Proguanil Hydrochloride	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	2