Primaquine Phosphate

Product NDC: 33261-671
11-digit product format: 332610671
Labeler code: 33261
Product ID: 33261-671_fe75c6ea-95b8-41a5-b92d-0332b75d1d38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primaquine Phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA204476
Marketing category: ANDA
Marketing start: 2014-08-01
Marketing end: 0000-00-00
Substance: PRIMAQUINE PHOSPHATE
Active strength: 15 mg/1
Pharmacologic classes: Antimalarial [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	33261-671		I	Inactivated by FDA	2026-08-17
excluded package	package	33261-671	33261-671-00	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-671	33261-671-14	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-671	33261-671-28	I	Inactivated by FDA	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 2 · 84 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	33261-671-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-671-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-671-00	`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	33261-671-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-671-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-671-00	`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	33261-671-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-671-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-671-00	`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	33261-671-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-671-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-671-00	`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	33261-671-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-671-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-671-00	`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	33261-671-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-671-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-671-00	`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	33261-671-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-671-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-671-00	`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	33261-671-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-671-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-671-00	`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	33261-671-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-671-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-671-00	`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	33261-671-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-671-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-671-00	`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	33261-671-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-671-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-671-00	`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	33261-671-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-671-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-671-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-671-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-671-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-671-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-671-28	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-671-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-671-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-671-28	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-671-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-671-00	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A204476-001	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB		2014-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204476-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204476-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204476-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204476-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204476-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204476-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204476-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204476-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204476-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204476-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204476-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204476-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204476-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204476-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204476-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204476-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204476-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204476-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204476-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204476-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204476-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204476-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204476-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204476-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204476-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204476-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204476-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204476-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204476-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204476-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204476-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204476-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204476-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204476-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204476-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204476-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204476-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204476-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204476-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204476-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204476-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
eb8524b4-2da6-dfe9-e2a2-512a68ffe536	Product name	2	20160815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-671-00	2020-01-31	C162847	48780-1	9d75b9d0-e434-f424-e053-dadaa90a57ce	PRIMAQUINE PHOSPHATE TABLETS, USP
33261-671-14	2020-01-31	C162847	48780-1	9d75b9d0-e434-f424-e053-dadaa90a57ce	PRIMAQUINE PHOSPHATE TABLETS, USP
33261-671-28	2020-01-31	C162847	48780-1	9d75b9d0-e434-f424-e053-dadaa90a57ce	PRIMAQUINE PHOSPHATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-671-00	Primaquine Phosphate	100 in 1 BOTTLE	TABLET	100	2
33261-671-14	Primaquine Phosphate	14 in 1 BOTTLE	TABLET	14	2
33261-671-28	Primaquine Phosphate	28 in 1 BOTTLE	TABLET	28	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-671	PRIMAQUINE PHOSPHATE TABLET [AIDAREX PHARMACEUTICALS LLC]	2	Legacy NDC, 3 package rows	20170909_5c920cdf-5c1e-43f7-a275-c72040005715.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primaquine Phosphate	PRIMAQUINE PHOSPHATE	PD-Rx Pharmaceuticals, Inc.	3f16166d-678e-51aa-e054-00144ff88e88	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204476 application number: ANDA204476
Primaquine Phosphate	PRIMAQUINE PHOSPHATE	Unichem Pharmaceuticals (USA), Inc.	0c8c2bc6-428b-40b6-8114-6df80290878d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204476 application number: ANDA204476

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0982HF78B	PRIMAQUINE PHOSPHATE	63-45-6	PRIMAQUINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904170	primaquine phosphate 26.3 MG Oral Tablet	PSN	5c920cdf-5c1e-43f7-a275-c72040005715	2
904170	primaquine phosphate 26.3 MG Oral Tablet	SCD	5c920cdf-5c1e-43f7-a275-c72040005715	2
904170	primaquine phosphate 26.3 MG (primaquine 15 MG) Oral Tablet	SY	5c920cdf-5c1e-43f7-a275-c72040005715	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-671-00	33261067100	100 in 1 BOTTLE	Historical
33261-671-14	33261067114	14 in 1 BOTTLE	Historical
33261-671-28	33261067128	28 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRIMAQUINE PHOSPHATE TABLETS, USP	Aidarex Pharmaceuticals LLC	2017-07-19	HUMAN PRESCRIPTION DRUG LABEL	2