Atovaquone and Proguanil Hydrochloride

Product NDC: 0378-4160
11-digit product format: 003784160
Labeler code: 0378
Product ID: 0378-4160_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: 62.5; 25 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 45.

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 · 90 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
2026-11-14 07:37:17	2026-10	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A202362-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2014-05-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202362-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2014-05-27	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A202362-001	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A202362-002	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A202362-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202362-002	AB	1	`c2088c7a36db…`
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…`

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	62.5 mg/1
PROGUANIL HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R71Y86M0WT	Internal UNII lookup
Y883P1Z2LT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
57d74d71-8cf8-4b10-9420-22954fae623c	Available on FDA.report

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
0378-4160-01	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
0378-4160-01	EA - Each	0378-4160	040974de-b75c-4eb6-be52-be1af571e1f7	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
0378-4160	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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4160-01	00378416001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)	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