Home NDC 16729-485 Hydroxychloroquine Sulfate
Product NDC 16729-485
11-digit product format 167290485
Labeler code 16729
Product ID 16729-485_4e68b971-e226-d3ff-e063-6294a90ae772
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxychloroquine Sulfate
Dosage form TABLET
Route ORAL
Labeler Accord Healthcare, Inc.,
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 2027-12-31
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 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979092 Internal RxNorm lookup 1119312 Internal RxNorm lookup 2569281 Internal RxNorm lookup 2569283 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 16729-485-01 Hydroxychloroquine Sulfate 100 in 1 BOTTLE TABLET 100 10 16729-485-16 Hydroxychloroquine Sulfate 500 in 1 BOTTLE TABLET 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-485 HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,] 8 Current NDC, Legacy NDC, 2 package rows 20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.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 16729-485-01 16729048501 100 TABLET in 1 BOTTLE (16729-485-01) 100 tablet 2021-01-26 0000-00-00 No No Current 16729-485-16 16729048516 500 TABLET in 1 BOTTLE (16729-485-16) 500 tablet 2020-05-12 0000-00-00 No No Current