Atovaquone and Proguanil Hydrochloride

Product NDC: 43063-393
Requested package NDC: 43063-393-14
11-digit product format: 430630393
Labeler code: 43063
Product ID: 43063-393_e6884998-d920-63e9-e053-2a95a90abda1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone and Proguanil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA091211
Marketing category: ANDA
Marketing start: 2011-09-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43063-393	43063-393-14	D	Discontinued by firm		2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-393	43063-393-14	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB		2011-01-12
A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB		2015-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091211-001	AB
A091211-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091211-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091211-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091211-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091211-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091211-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091211-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091211-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091211-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091211-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091211-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091211-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091211-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091211-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091211-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091211-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091211-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091211-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091211-002	AB	1	`782e0a99824c…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Bryant Ranch Prepack	e4ff57f7-07af-4872-ac3a-c521e098ccfe	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	BluePoint Laboratories	ad25ab65-42aa-48f6-b5ed-247f3685d5bf	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride Pediatric	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC	Glenmark Pharmaceuticals Inc.,USA	4b80d087-eaa7-448f-967e-344de7f16436	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Proficient Rx LP	e74b00fc-8743-4e9d-8a83-aab8e531b3ba	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-393-14	EA - Each	43063-393	fa01e0f9-e05f-41a9-91d6-07380e8edeef	1	2013-02-13
43063-393-20	EA - Each	43063-393	54736432-468d-43e6-b4da-1f955ffda6c7	1	2013-06-04

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 [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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-393	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	16	Legacy NDC	20241012_a79fb027-66a6-47c8-9ee7-ce9367e9ec6e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-393-14	43063039314	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-14)	2012-07-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	16