Primaquine Phosphate

Product NDC: 0024-1596
11-digit product format: 000241596
Labeler code: 0024
Product ID: 0024-1596_7e15f87d-f34f-4ec2-9da8-a041db792623
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primaquine Phosphate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sanofi-Aventis U.S. LLC
Application: NDA008316
Marketing category: NDA
Marketing start: 2011-04-15
Substance: PRIMAQUINE PHOSPHATE
Active strength: 15 mg/1
Pharmacologic classes: Antimalarial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
N008316-001	PRIMAQUINE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	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
N008316-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008316-001	PRIMAQUINE	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N008316-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008316-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008316-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008316-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008316-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008316-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008316-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008316-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008316-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008316-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008316-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008316-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008316-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008316-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008316-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008316-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008316-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008316-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008316-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008316-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008316-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008316-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008316-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008316-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008316-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008316-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008316-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008316-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008316-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008316-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008316-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008316-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008316-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008316-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008316-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008316-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008316-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008316-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008316-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008316-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Primaquine Phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRIMAQUINE PHOSPHATE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H0982HF78B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904170	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
1bfbf4ae-81b8-4160-a00d-6322aadd4b59	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
eb8524b4-2da6-dfe9-e2a2-512a68ffe536	Product name	2	20160815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0024-1596-01	Primaquine Phosphate	100 in 1 BOTTLE	TABLET, FILM COATED	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-1596-01	EA - Each	0024-1596	05cf2232-eb84-4719-92fe-5974e86a7beb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Primaquine Phosphate	ACTIVE INGREDIENT	H0982HF78B	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
primaquine	ACTIVE MOIETY	MVR3634GX1	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Hypromellose 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	9
PRIMAQUINE PHOSPHATE	ACTIVE INGREDIENT	H0982HF78B	PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
PRIMAQUINE	ACTIVE MOIETY	MVR3634GX1	PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-1596	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	19	Current NDC, Legacy NDC, 1 package rows	20250430_1bfbf4ae-81b8-4160-a00d-6322aadd4b59.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primaquine Phosphate	PRIMAQUINE PHOSPHATE	Sanofi-Aventis U.S. LLC	1bfbf4ae-81b8-4160-a00d-6322aadd4b59	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008316 application number: NDA008316 ndc (product): 0024-1596

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	1bfbf4ae-81b8-4160-a00d-6322aadd4b59	20
904170	primaquine phosphate 26.3 MG Oral Tablet	SCD	1bfbf4ae-81b8-4160-a00d-6322aadd4b59	20
904170	primaquine phosphate 26.3 MG (primaquine 15 MG) Oral Tablet	SY	1bfbf4ae-81b8-4160-a00d-6322aadd4b59	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-1596-01	00024159601	100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01)	2011-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRIMAQUINE PHOSPHATE TABLETS, USP	Sanofi-Aventis U.S. LLC \| Bayer Healthcare LLC \| Curia New York, Inc. \| Bausch Health Companies Inc.	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	20
PRIMAQUINE PHOSPHATE TABLETS, USP	PD-Rx Pharmaceuticals, Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	22