Atovaquone and Proguanil HCl

Product NDC: 43063-522
11-digit product format: 430630522
Labeler code: 43063
Product ID: 43063-522_e71787c0-36b5-1e75-e053-2995a90a8fd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atovaquone and proguanil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA021078
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-07-27
Marketing end: 0000-00-00
Substance: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength: 250 mg/1; mg/1
Pharmacologic classes: Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-522		D	Discontinued by firm	2026-08-17
excluded package	package	43063-522	43063-522-68	D	Discontinued by firm	2026-08-17
excluded package	package	43063-522	43063-522-69	D	Discontinued by firm	2026-08-17
excluded package	package	43063-522	43063-522-73	D	Discontinued by firm	2026-08-17

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-522-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-522-73	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-522-68	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-522-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-522-73	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-522-68	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-522-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-522-73	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-522-68	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-522-69	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-522-73	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-522-68	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-522-69	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-522-73	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-522-68	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-522-69	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-522-73	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-522-68	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-522-69	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-522-73	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-522-68	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-522-69	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-522-73	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-522-68	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-522-69	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-522-73	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-522-68	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-522-69	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-522-73	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-522-68	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-522-69	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-522-73	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-522-68	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-522-69	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-522-73	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-522-68	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021078-001	MALARONE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14
N021078-002	MALARONE PEDIATRIC	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021078-001	AB
N021078-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021078-001	MALARONE	250MG;100MG	TABLET / ORAL	AB	RLD, RS	2000-07-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021078-002	MALARONE PEDIATRIC	62.5MG;25MG	TABLET / ORAL	AB	RLD	2000-07-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021078-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021078-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021078-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021078-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021078-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021078-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021078-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021078-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021078-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021078-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021078-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021078-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021078-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021078-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021078-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021078-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021078-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021078-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021078-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021078-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021078-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021078-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021078-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021078-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021078-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021078-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021078-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021078-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021078-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021078-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021078-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021078-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021078-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021078-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021078-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021078-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021078-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021078-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021078-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021078-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-522-07	EA - Each	43063-522	e1eeb6d0-2257-4e96-afef-b5bdb5ff7c97	1	2015-02-02
43063-522-14	EA - Each	43063-522	e4aea555-343d-4fcd-8703-3ade3129492c	1	2016-03-04
43063-522-20	EA - Each	43063-522	56efcf67-e9a9-44ba-9743-7d7504486218	1	2014-08-01
43063-522-24	EA - Each	43063-522	0c3449fb-d541-41bc-8576-fc870b914d44	1	2015-10-02
43063-522-68	EA - Each	43063-522	5c31a20b-bafc-4a4c-90ec-08174ce26cf4	1	2015-02-02
43063-522-69	EA - Each	43063-522	e48c64b2-23db-42d9-acb4-b807f882f9cd	1	2015-02-02
43063-522-73	EA - Each	43063-522	ad24caee-3aa4-4f54-be1a-626964932ef3	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MALARONE	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	GlaxoSmithKline LLC	fc22e8d8-3bfb-4f70-a599-dd81262a4887	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021078 application number: NDA021078
Atovaquone and Proguanil HCl	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	A-S Medication Solutions	593baf3d-bd9e-4a44-8f90-125aa4a7a99e	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021078 application number: NDA021078
Atovaquone and Proguanil HCl	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Prasco Laboratories	7069521a-c7f9-4e8d-99b8-0cb5c971e7cf	2022-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021078 application number: NDA021078

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-522-07	43063052207	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-07)	2015-01-30	0000-00-00	No	No	Current
43063-522-14	43063052214	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-14)	2015-01-30	0000-00-00	No	No	Current
43063-522-20	43063052220	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-20)	2015-01-30	0000-00-00	No	No	Current
43063-522-24	43063052224	24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-24)	2015-01-30	0000-00-00	No	No	Current
43063-522-68	43063052268	190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-68)	2015-01-30	0000-00-00	No	No	Current
43063-522-69	43063052269	280 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-69)	2015-01-30	0000-00-00	No	No	Current
43063-522-73	43063052273	375 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-73)	2015-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil HCl	PD-Rx Pharmaceuticals, Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	28