Pyrimethamine

Product NDC: 72647-330
11-digit product format: 726470330
Labeler code: 72647
Product ID: 72647-330_d61ffa19-149f-4402-884a-4d16becb80ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pyrimethamine
Dosage form: TABLET
Route: ORAL
Labeler: OAKRUM PHARMA, LLC
Application: NDA008578
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-03-13
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72647-330	72647-330-10	D	Discontinued by firm		2026-08-03
excluded package	package	72647-330	72647-330-30	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	72647-330-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	72647-330-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	72647-330-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	72647-330-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	72647-330-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	72647-330-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	72647-330-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	72647-330-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	72647-330-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	72647-330-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	72647-330-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	72647-330-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	72647-330-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	72647-330-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	72647-330-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	72647-330-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	72647-330-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	72647-330-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	72647-330-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	72647-330-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	72647-330-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	72647-330-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	72647-330-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	72647-330-10	`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: Pyrimethamine
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198182	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
8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a	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
72647-330-01	Pyrimethamine	100 in 1 BOTTLE, PLASTIC	TABLET	100	4
72647-330-03	Pyrimethamine	30 in 1 BOTTLE, PLASTIC	TABLET	30	4
72647-330-10	Pyrimethamine	100 in 1 BOTTLE, PLASTIC	TABLET	100	4
72647-330-30	Pyrimethamine	30 in 1 BOTTLE, PLASTIC	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72647-330-01	EA - Each	72647-330	dcbe74db-c811-4568-aad3-bcaab8e92f35	1	2020-04-20
72647-330-03	EA - Each	72647-330	3c35a1ff-ac20-4a03-9c3b-858b0353515f	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72647-330	PYRIMETHAMINE TABLET [OAKRUM PHARMA, LLC]	4	Current NDC, Legacy NDC, 4 package rows	20211201_8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a.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
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 ndc (product): 72647-330

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
198182	pyrimethamine 25 MG Oral Tablet	PSN	8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a	4
198182	pyrimethamine 25 MG Oral Tablet	SCD	8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72647-330-01	72647033001	100 TABLET in 1 BOTTLE, PLASTIC (72647-330-01)	100 tablet	2020-03-13	0000-00-00	No	No	Current
72647-330-03	72647033003	30 TABLET in 1 BOTTLE, PLASTIC (72647-330-03)	30 tablet	2020-03-13	0000-00-00	No	No	Current
72647-330-10	72647033010	100 in 1 BOTTLE, PLASTIC						Historical
72647-330-30	72647033030	30 in 1 BOTTLE, PLASTIC						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyrimethamine	OAKRUM PHARMA, LLC \| Fukuzyu Pharmaceutical Co., Ltd. \| Patheon Manufacturing Services LLC \| Novitium Pharma LLC	2021-11-11	HUMAN PRESCRIPTION DRUG LABEL	4