Home NDC 0378-0373-01 HYDROXYCHLOROQUINE SULFATE
Product NDC 0378-0373
Requested package NDC 0378-0373-01
11-digit product format 003780373
Labeler code 0378
Product ID 0378-0373_51167105-95c4-402e-97a4-df909931d7ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYCHLOROQUINE SULFATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA040274
Marketing category ANDA
Marketing start 1998-06-18
Marketing end 2023-04-30
Substance HYDROXYCHLOROQUINE SULFATE
Active strength 200 mg/1
Pharmacologic classes Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A040274-001 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040274-001 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 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040274-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL AB 1998-05-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYCHLOROQUINE SULFATE ACTIVE INGREDIENT 8Q2869CNVH HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 HYDROXYCHLOROQUINE ACTIVE MOIETY 4QWG6N8QKH HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-0373-01 00378037301 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0373-01) 1998-06-18 2023-04-30 No No Current