Home NDC 42291-510 PRIMAQUINE PHOSPHATE
Product NDC 42291-510
11-digit product format 422910510
Labeler code 42291
Product ID 42291-510_4ba945a5-47a2-e791-e063-6294a90a9f8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRIMAQUINE PHOSPHATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA206043
Marketing category ANDA
Marketing start 2019-02-21
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 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 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-09-29 23:25 UTC 2022-09 A206043-001 PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET / ORAL AB 2016-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206043-001 PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET / ORAL AB 2016-06-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-510-01 PRIMAQUINE PHOSPHATE 100 in 1 BOTTLE TABLET, FILM COATED 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-510 PRIMAQUINE PHOSPHATE TABLET, FILM COATED [AVKARE] 3 Current NDC, Legacy NDC, 1 package rows 20240110_82465385-4602-7f46-e053-2991aa0a9fdf.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42291-510-01 42291051001 100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01) 2019-02-21 0000-00-00 No No Current