PRIMAQUINE PHOSPHATE

Product NDC: 50742-191
11-digit product format: 507420191
Labeler code: 50742
Product ID: 50742-191_0fb59114-6477-4616-88ab-48fdc00858f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRIMAQUINE PHOSPHATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA206043
Marketing category: ANDA
Marketing start: 2018-01-23
Substance: PRIMAQUINE PHOSPHATE
Active strength: 15 mg/1
Pharmacologic classes: Antimalarial [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206043-001	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB		2016-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206043-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206043-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2016-06-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206043-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206043-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206043-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206043-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206043-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206043-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206043-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206043-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206043-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206043-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206043-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206043-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206043-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206043-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206043-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206043-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206043-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206043-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206043-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206043-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206043-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206043-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206043-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206043-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206043-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206043-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206043-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206043-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206043-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206043-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206043-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206043-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206043-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206043-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206043-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206043-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206043-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206043-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206043-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206043-001	AB	1	`f41ea6bd6efb…`

Additional Listing Data#

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

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
09531382-2e06-4164-a7e1-169a1488788a	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
50742-191-01	PRIMAQUINE PHOSPHATE	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		4
50742-191-05	PRIMAQUINE PHOSPHATE	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-191-05	EA - Each	50742-191	93ec9c45-534d-48af-8e4a-2506bbddf4e7	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-191	PRIMAQUINE PHOSPHATE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20181220_09531382-2e06-4164-a7e1-169a1488788a.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	AvKARE	82465385-4602-7f46-e053-2991aa0a9fdf	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206043 application number: ANDA206043
PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	Ingenus Pharmaceuticals, LLC	09531382-2e06-4164-a7e1-169a1488788a	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206043 application number: ANDA206043 ndc (product): 50742-191

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	82465385-4602-7f46-e053-2991aa0a9fdf	5
904170	primaquine phosphate 26.3 MG Oral Tablet	SCD	82465385-4602-7f46-e053-2991aa0a9fdf	5
904170	primaquine phosphate 26.3 MG (primaquine 15 MG) Oral Tablet	SY	82465385-4602-7f46-e053-2991aa0a9fdf	5
904170	primaquine phosphate 26.3 MG Oral Tablet	PSN	09531382-2e06-4164-a7e1-169a1488788a	4
904170	primaquine phosphate 26.3 MG Oral Tablet	SCD	09531382-2e06-4164-a7e1-169a1488788a	4
904170	primaquine phosphate 26.3 MG (primaquine 15 MG) Oral Tablet	SY	09531382-2e06-4164-a7e1-169a1488788a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-191-01	50742019101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)	2018-01-23	0000-00-00	No	No	Current
50742-191-05	50742019105	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)	2018-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRIMAQUINE PHOSPHATE TABLETS, USP	AvKARE	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	5
PRIMAQUINE PHOSPHATE TABLETS, USP	Ingenus Pharmaceuticals, LLC \| Novast Laboratories, Ltd.	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	4