Home NDC 43063-721-28 Primaquine Phosphate
Product NDC 43063-721
Requested package NDC 43063-721-28
11-digit product format 430630721
Labeler code 43063
Product ID 43063-721_51a584d0-f172-e260-e063-6394a90a4547
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primaquine Phosphate
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA204476
Marketing category ANDA
Marketing start 2014-08-01
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 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 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 · 43 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 2026-09-14 22:38:34 2026-08 A204476-001 PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET / ORAL AB 2014-02-25 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 43063-721-14 Primaquine Phosphate 14 in 1 BOTTLE, PLASTIC TABLET 14 12 43063-721-28 Primaquine Phosphate 28 in 1 BOTTLE, PLASTIC TABLET 28 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-721 PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240815_3f16166d-678e-51aa-e054-00144ff88e88.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 Units Marketing start Marketing end Sample Exclude flag Status 43063-721-28 43063072128 28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28) 28 tablet 2016-10-17 0000-00-00 No No Current