Home NDC 42385-971 HYDROXYCHLOROQUINE SULFATE
Product NDC 42385-971
11-digit product format 423850971
Labeler code 42385
Product ID 42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYCHLOROQUINE SULFATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA210959
Marketing category ANDA
Marketing start 2023-03-06
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 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 A210959-001 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210959-001 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 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL 2019-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL 2019-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210959-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 2019-01-15 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 42385-971-01 HYDROXYCHLOROQUINE SULFATE 100 in 1 BOTTLE TABLET, FILM COATED 100 2 42385-971-05 HYDROXYCHLOROQUINE SULFATE 500 in 1 BOTTLE TABLET, FILM COATED 500 2 42385-971-11 HYDROXYCHLOROQUINE SULFATE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 42385-971-60 HYDROXYCHLOROQUINE SULFATE 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-971 HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [LAURUS LABS LIMITED] 2 Current NDC, 4 package rows 20240125_04d8fdbf-8829-4469-a341-8af2a2d91ccc.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 Marketing start Sample Exclude flag Status 42385-971-01 42385097101 100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01) 2023-03-06 No No Current 42385-971-05 42385097105 500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05) 2023-03-06 No No Current 42385-971-11 42385097111 1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11) 2023-03-06 No No Current 42385-971-60 42385097160 60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60) 2023-03-06 No No Current