Home NDC 50090-4659 Hydroxychloroquine Sulfate
Product NDC 50090-4659
11-digit product format 500904659
Labeler code 50090
Product ID 50090-4659_755581f8-6167-46af-991f-9cb92a16d06c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxychloroquine Sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA210577
Marketing category ANDA
Marketing start 2018-05-17
Substance HYDROXYCHLOROQUINE SULFATE
Active strength 200 mg/1
Pharmacologic classes Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-4659 50090-4659-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-4659 50090-4659-3 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A210577-001 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210577-001 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 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210577-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2018-05-15 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 Hydroxychloroquine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYCHLOROQUINE SULFATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8Q2869CNVH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979092 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 50090-4659-1 Hydroxychloroquine Sulfate 60 in 1 BOTTLE TABLET, FILM COATED 60 12 50090-4659-2 Hydroxychloroquine Sulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 12 50090-4659-3 Hydroxychloroquine Sulfate 12 in 1 BOTTLE TABLET, FILM COATED 12 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4659 HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 10 Current NDC, Legacy NDC, 3 package rows 20250430_87076a61-ce76-475b-ac6d-c33ba617195d.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 · 5 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 50090-4659-1 50090465901 60 TABLET, FILM COATED in 1 BOTTLE (50090-4659-1) 2019-10-28 0000-00-00 No No Current 50090-4659-2 50090465902 90 TABLET, FILM COATED in 1 BOTTLE (50090-4659-2) 2019-10-28 0000-00-00 No No Current 50090-4659-3 50090465903 12 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3) 2020-03-17 0000-00-00 No No Current