Home NDC 60429-035-28 Primaquine Phosphate
Product NDC 60429-035
Requested package NDC 60429-035-28
11-digit product format 604290035
Labeler code 60429
Product ID 60429-035_9e68a0f6-3e23-b677-e053-2a95a90a30c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primaquine Phosphate
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply
Application ANDA204476
Marketing category ANDA
Marketing start 2014-02-25
Marketing end 0000-00-00
Substance PRIMAQUINE PHOSPHATE
Active strength 15 mg/1
Pharmacologic classes Antimalarial [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A204476-001 PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET / ORAL AB 2014-02-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRIMAQUINE PHOSPHATE ACTIVE INGREDIENT H0982HF78B PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 PRIMAQUINE ACTIVE MOIETY MVR3634GX1 PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PRIMAQUINE PHOSPHATE (PRIMAQUINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-035 PRIMAQUINE PHOSPHATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 11 Legacy NDC 20241213_4933e6d9-0e9e-415f-8325-25212c6fe297.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-035-28 60429003528 28 TABLET in 1 BOTTLE (60429-035-28) 28 tablet 2014-05-08 0000-00-00 No No Current