Home NDC 76385-102 Primaquine Phosphate
Product NDC 76385-102
11-digit product format 763850102
Labeler code 76385
Product ID 76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primaquine Phosphate
Dosage form TABLET
Route ORAL
Labeler Unichem Pharmaceuticals (USA), 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 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.
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 76385-102-01 Primaquine Phosphate 100 in 1 BOTTLE TABLET 100 9
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 Primaquine Phosphate ACTIVE INGREDIENT H0982HF78B PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 primaquine ACTIVE MOIETY MVR3634GX1 PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76385-102 PRIMAQUINE PHOSPHATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] 7 Current NDC, Legacy NDC, 1 package rows 20250417_0c8c2bc6-428b-40b6-8114-6df80290878d.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 76385-102-01 76385010201 100 TABLET in 1 BOTTLE (76385-102-01) 100 tablet 2014-08-01 0000-00-00 No No Current