Daraprim

Product NDC: 69413-330
11-digit product format: 694130330
Labeler code: 69413
Product ID: 69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pyrimethamine
Dosage form: TABLET
Route: ORAL
Labeler: Vyera Pharmaceuticals LLC
Application: NDA008578
Marketing category: NDA
Marketing start: 1953-01-23
Substance: PYRIMETHAMINE
Active strength: 25 mg/1
Pharmacologic classes: Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	69413-330	69413-330-06	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 · 12 matching rows.

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

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N008578-001	DARAPRIM	PYRIMETHAMINE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N008578-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008578-001	DARAPRIM	25MG	TABLET / ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008578-001	DARAPRIM	25MG	TABLET / ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008578-001	DARAPRIM	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N008578-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008578-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008578-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008578-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008578-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008578-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008578-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008578-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008578-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008578-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008578-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008578-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008578-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008578-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008578-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008578-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008578-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N008578-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008578-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008578-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008578-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008578-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008578-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008578-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008578-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008578-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008578-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008578-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008578-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008578-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008578-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008578-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008578-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008578-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008578-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008578-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N008578-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Daraprim
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRIMETHAMINE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Z3614QOX8W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198182	Internal RxNorm lookup
201912	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
5368616d-6520-6f6e-2053-686b72656c69	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
927bc290-af6b-41d8-9ce2-cbb0b8d5cf88	Product name	3	20240102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69413-330-06	Daraprim	6 in 1 BOTTLE, PLASTIC	TABLET	6	8
69413-330-10	Daraprim	100 in 1 BOTTLE, PLASTIC	TABLET	100	8
69413-330-30	Daraprim	30 in 1 BOTTLE, PLASTIC	TABLET	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69413-330-10	EA - Each	69413-330	a6b9f96b-d49f-4cc7-b1db-d089714ef7ef	1	2016-03-04
69413-330-30	EA - Each	69413-330	2d05ab24-40ce-4a09-bb22-05f154dd67e3	1	2016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRIMETHAMINE	ACTIVE INGREDIENT	Z3614QOX8W	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2
PYRIMETHAMINE	ACTIVE MOIETY	Z3614QOX8W	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69413-330	DARAPRIM (PYRIMETHAMINE) TABLET [VYERA PHARMACEUTICALS LLC]	8	Current NDC, Legacy NDC, 3 package rows	20211202_5368616d-6520-6f6e-2053-686b72656c69.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daraprim	PYRIMETHAMINE	TILDE Sciences LLC	f634f34b-0952-4dd3-9da3-f84b6ab823de	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008578 application number: NDA008578
Daraprim	PYRIMETHAMINE	Vyera Pharmaceuticals LLC	5368616d-6520-6f6e-2053-686b72656c69	2021-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008578 application number: NDA008578 ndc (product): 69413-330
Pyrimethamine	PYRIMETHAMINE	OAKRUM PHARMA, LLC	8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a	2021-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008578 application number: NDA008578

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z3614QOX8W	PYRIMETHAMINE	58-14-0	PYRIMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
201912	DARAPRIM 25 MG Oral Tablet	PSN	5368616d-6520-6f6e-2053-686b72656c69	8
198182	pyrimethamine 25 MG Oral Tablet	PSN	5368616d-6520-6f6e-2053-686b72656c69	8
201912	pyrimethamine 25 MG Oral Tablet [Daraprim]	SBD	5368616d-6520-6f6e-2053-686b72656c69	8
198182	pyrimethamine 25 MG Oral Tablet	SCD	5368616d-6520-6f6e-2053-686b72656c69	8
201912	Daraprim 25 MG Oral Tablet	SY	5368616d-6520-6f6e-2053-686b72656c69	8
201912	DARAPRIM 25 MG Oral Tablet	PSN	f634f34b-0952-4dd3-9da3-f84b6ab823de	1
198182	pyrimethamine 25 MG Oral Tablet	PSN	f634f34b-0952-4dd3-9da3-f84b6ab823de	1
201912	pyrimethamine 25 MG Oral Tablet [Daraprim]	SBD	f634f34b-0952-4dd3-9da3-f84b6ab823de	1
198182	pyrimethamine 25 MG Oral Tablet	SCD	f634f34b-0952-4dd3-9da3-f84b6ab823de	1
201912	Daraprim 25 MG Oral Tablet	SY	f634f34b-0952-4dd3-9da3-f84b6ab823de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69413-330-06	69413033006	6 in 1 BOTTLE, PLASTIC						Historical
69413-330-10	69413033010	100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10)	100 tablet	1953-01-23	0000-00-00	No	No	Current
69413-330-30	69413033030	30 TABLET in 1 BOTTLE, PLASTIC (69413-330-30)	30 tablet	1953-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DARAPRIM ® (pyrimethamine)	TILDE Sciences LLC \| Nutra-Med Packaging LLC	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
DARAPRIM ® (pyrimethamine)	Vyera Pharmaceuticals LLC \| Fukuzyu Pharmaceutical Co., Ltd. \| Patheon Manufacturing Services LLC \| Novitium Pharma LLC	2021-11-11	HUMAN PRESCRIPTION DRUG LABEL	8