Home NDC 33261-671 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
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.
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 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A204476-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204476-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204476-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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.
DailyMed RxNorm Mappings# 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