FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
16729-563
Requested package NDC
16729-563-01
11-digit product format
167290563
Labeler code
16729
Product ID
16729-563_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
2021-09-28
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
400 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213342-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2020-04-07
A213342-002HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE100MGTABLET / ORALAB2021-08-18
A213342-003HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE300MGTABLET / ORALAB2021-08-18
A213342-004HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE400MGTABLET / ORALABRS2021-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A213342-001AB
A213342-002AB
A213342-003AB
A213342-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213342-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2020-04-07a50c72e98297…
2026-08-01 22:54:322026-06A213342-002HYDROXYCHLOROQUINE SULFATE100MGTABLET / ORALAB2021-08-18a50c72e98297…
2026-08-01 22:54:322026-06A213342-003HYDROXYCHLOROQUINE SULFATE300MGTABLET / ORALAB2021-08-18a50c72e98297…
2026-08-01 22:54:322026-06A213342-004HYDROXYCHLOROQUINE SULFATE400MGTABLET / ORALABRS2021-08-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213342-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213342-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213342-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A213342-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAccord Healthcare, Inc.,84b00366-96ef-41e1-bac6-5d24acdb9e1d2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213342
application number: ANDA213342
ndc (package): 16729-563-01
ndc (product): 16729-563
ndc11 (package): 16729056301
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutionsb4dca05a-745f-4c15-b731-1e99176cf44c2023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213342
application number: ANDA213342

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE400 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979092Internal RxNorm lookup
1119312Internal RxNorm lookup
2569281Internal RxNorm lookup
2569283Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84b00366-96ef-41e1-bac6-5d24acdb9e1dAvailable 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
16729-563-01Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET10010
16729-563-16Hydroxychloroquine Sulfate500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-563-01EA - Each16729-5637862900f-d7bb-42e9-a79c-a81d1037726012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-563HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,]8Current NDC, Legacy NDC, 2 package rows20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569281hydroxychloroquine sulfate 100 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569283hydroxychloroquine sulfate 300 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
1119312hydroxychloroquine sulfate 400 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569281hydroxychloroquine sulfate 100 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569283hydroxychloroquine sulfate 300 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
1119312hydroxychloroquine sulfate 400 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY84b00366-96ef-41e1-bac6-5d24acdb9e1d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-563-0116729056301100 TABLET in 1 BOTTLE (16729-563-01) 100 tablet2021-09-280000-00-00NoNoCurrent