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

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	R71Y86M0WT, Y883P1Z2LT
Rxcui	864675, 864681

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	SPL version
68462-404-01	Atovaquone and Proguanil Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
68462-404-10	Atovaquone and Proguanil Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	14
68462-404-44	Atovaquone and Proguanil Hydrochloride	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	14
68462-404-60	Atovaquone and Proguanil Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
68462-404-67	Atovaquone and Proguanil Hydrochloride	2 in 1 CARTON	TABLET, FILM COATED	2	14
68462-404-90	Atovaquone and Proguanil Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-404-01	EA - Each	68462-404	7aebf8d2-18ce-4940-9ef0-b792627544c7	1	2012-07-24
68462-404-44	EA - Each	68462-404	5c44903b-55a9-4fb3-87f1-76aa833e35d0	1	2026-02-05
68462-404-67	EA - Each	68462-404	a25082e5-f5e0-4dc7-a274-51d076af0b65	1	2012-07-24

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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE 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 INGREDIENT	36SFW2JZ0W	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	7
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	5
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-404	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]	12	Current NDC, Legacy NDC, 6 package rows	20230111_4b80d087-eaa7-448f-967e-344de7f16436.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	4b80d087-eaa7-448f-967e-344de7f16436	14
864681	atovaquone 62.5 MG / proguanil HCl 25 MG Oral Tablet	PSN	4b80d087-eaa7-448f-967e-344de7f16436	14
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	4b80d087-eaa7-448f-967e-344de7f16436	14
864681	atovaquone 62.5 MG / proguanil hydrochloride 25 MG Oral Tablet	SCD	4b80d087-eaa7-448f-967e-344de7f16436	14
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	e74b00fc-8743-4e9d-8a83-aab8e531b3ba	6
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	e74b00fc-8743-4e9d-8a83-aab8e531b3ba	6
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	f8659107-ef6b-4142-a4b8-6934aae07f41	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	01cb577f-c355-b88f-e063-6394a90af9ce	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	03b1a85e-16ff-7cec-e063-6394a90a98dc	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	13eef6e5-4534-3009-e054-00144ff8d46c	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	186ad795-f19a-4df6-8f81-b2028a3da229	1
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	c50d51ab-23c2-45cb-8f68-08f3454fb59b	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	f8659107-ef6b-4142-a4b8-6934aae07f41	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	c50d51ab-23c2-45cb-8f68-08f3454fb59b	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	186ad795-f19a-4df6-8f81-b2028a3da229	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	13eef6e5-4534-3009-e054-00144ff8d46c	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	03b1a85e-16ff-7cec-e063-6394a90a98dc	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	01cb577f-c355-b88f-e063-6394a90af9ce	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-404-01	68462040401	100 TABLET, FILM COATED in 1 BOTTLE (68462-404-01)		2011-09-15	0000-00-00	No	No	Current
68462-404-10	68462040410	1000 in 1 BOTTLE						Historical
68462-404-44	68462040444	12 in 1 BLISTER PACK						Historical
68462-404-60	68462040460	60 in 1 BOTTLE						Historical
68462-404-67	68462040467	2 BLISTER PACK in 1 CARTON (68462-404-67) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44)	2 blister pack	2011-09-15	0000-00-00	No	No	Current
68462-404-90	68462040490	90 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	Glenmark Pharmaceuticals Inc.,USA \| Glenmark Pharmaceuticals Limited	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	14
Atovaquone and Proguanil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	16
Atovaquone and Proguanil Hydrochloride	Proficient Rx LP	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	6
Atovaquone and Proguanil Hydrochloride	NuCare Pharmaceuticals,Inc.	2023-08-24	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride	NuCare Pharmaceuticals,Inc.	2023-07-31	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride	Blenheim Pharmacal, Inc.	2015-04-17	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride Tablets	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride Tablets	Physicians Total Care, Inc.	2013-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride Tablets	Aidarex Pharmaceuticals LLC	2012-09-10	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone and Proguanil Hydrochloride Tablets	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1

Atovaquone and Proguanil Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#