Home NDC 50090-6280 Hydroxychloroquine Sulfate
Product NDC 50090-6280
11-digit product format 500906280
Labeler code 50090
Product ID 50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxychloroquine Sulfate
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA213342
Marketing category ANDA
Marketing start 2020-05-12
Substance HYDROXYCHLOROQUINE SULFATE
Active strength 200 mg/1
Pharmacologic classes Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213342-001 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 A213342-002 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 A213342-003 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 A213342-004 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 4 · 144 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 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213342-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2020-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213342-002 HYDROXYCHLOROQUINE SULFATE 100MG TABLET / ORAL AB 2021-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213342-003 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL AB 2021-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213342-004 HYDROXYCHLOROQUINE SULFATE 400MG TABLET / ORAL AB RS 2021-08-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxychloroquine Sulfate
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6280-1 Hydroxychloroquine Sulfate 60 in 1 BOTTLE TABLET 60 3 50090-6280-2 Hydroxychloroquine Sulfate 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6280 HYDROXYCHLOROQUINE SULFATE TABLET [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 2 package rows 20231101_b4dca05a-745f-4c15-b731-1e99176cf44c.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 50090-6280-1 50090628001 60 TABLET in 1 BOTTLE (50090-6280-1) 60 tablet 2022-12-15 0000-00-00 No No Current 50090-6280-2 50090628002 90 TABLET in 1 BOTTLE (50090-6280-2) 90 tablet 2022-12-15 0000-00-00 No No Current