Plaquenil

Product NDC
59212-562
11-digit product format
592120562
Labeler code
59212
Product ID
59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA009768
Marketing category
NDA
Marketing start
2013-06-28
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N009768-001PLAQUENILHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N009768-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N009768-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009768-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N009768-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009768-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009768-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009768-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009768-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009768-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009768-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009768-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009768-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009768-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009768-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009768-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009768-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009768-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009768-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009768-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009768-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009768-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009768-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N009768-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009768-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009768-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009768-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N009768-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N009768-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009768-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009768-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009768-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009768-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009768-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009768-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009768-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N009768-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N009768-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009768-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009768-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009768-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009768-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Plaquenil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8Q2869CNVHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979092Internal RxNorm lookup
979094Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34496b43-05a2-45fb-a769-52b12e099341Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59212-562-10Plaquenil100 in 1 BOTTLETABLET10015
59212-562-11Plaquenil100 in 1 BOTTLETABLET10015
59212-562-60Plaquenil60 in 1 BOTTLETABLET6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-562-10EA - Each59212-562c4ec417b-969f-4e45-b8fe-b6d720c0f09412016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydroxychloroquine sulfateACTIVE INGREDIENT8Q2869CNVHPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
hydroxychloroquineACTIVE MOIETY4QWG6N8QKHPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Calcium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENTL11K75P92JPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
shellacINACTIVE INGREDIENT46N107B71OPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-562PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [ADVANZ PHARMA (US) CORP.]14Current NDC, Legacy NDC, 3 package rows20250104_34496b43-05a2-45fb-a769-52b12e099341.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlaquenilHYDROXYCHLOROQUINE SULFATEAdvanz Pharma (US) Corp.34496b43-05a2-45fb-a769-52b12e0993412026-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768
ndc (product): 59212-562
PlaquenilHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLCeb26c050-fc41-4183-9f8c-86351335fa642024-04-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768
PlaquenilHYDROXYCHLOROQUINE SULFATEProficient Rx LP8aec894d-5711-4079-b167-240713bf04f22020-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN34496b43-05a2-45fb-a769-52b12e09934115
979094Plaquenil 200 MG Oral TabletPSN34496b43-05a2-45fb-a769-52b12e09934115
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBD34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY34496b43-05a2-45fb-a769-52b12e09934115
979094Plaquenil 200 MG Oral TabletSY34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNeb26c050-fc41-4183-9f8c-86351335fa644
979094Plaquenil 200 MG Oral TabletPSNeb26c050-fc41-4183-9f8c-86351335fa644
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBDeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYeb26c050-fc41-4183-9f8c-86351335fa644
979094Plaquenil 200 MG Oral TabletSYeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa3c311ff-2f87-7780-e053-2995a90aac4e2
979094Plaquenil 200 MG Oral TabletPSNa3c311ff-2f87-7780-e053-2995a90aac4e2
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBDa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa3c311ff-2f87-7780-e053-2995a90aac4e2
979094Plaquenil 200 MG Oral TabletSYa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN8aec894d-5711-4079-b167-240713bf04f21
979094Plaquenil 200 MG Oral TabletPSN8aec894d-5711-4079-b167-240713bf04f21
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBD8aec894d-5711-4079-b167-240713bf04f21
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD8aec894d-5711-4079-b167-240713bf04f21
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY8aec894d-5711-4079-b167-240713bf04f21
979094Plaquenil 200 MG Oral TabletSY8aec894d-5711-4079-b167-240713bf04f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-562-1059212056210100 TABLET in 1 BOTTLE (59212-562-10) 100 tablet2013-06-280000-00-00NoNoCurrent
59212-562-1159212056211100 TABLET in 1 BOTTLE (59212-562-11) 100 tablet2020-08-100000-00-00NoNoCurrent
59212-562-605921205626060 TABLET in 1 BOTTLE (59212-562-60) 60 tablet2019-01-050000-00-00NoNoCurrent