Hydroxychloroquine Sulfate Tablets, Usp

SPL v8

SPL

SPL Set ID 1aa44bff-9a62-48b4-a520-98d7d524e3a9

Route

ORAL

Published

Effective Date 2022-10-10

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydroxychloroquine (200 mg)

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: ZC38 Shape: oval Color: white Size: 13 mm Score: 1

Marketing Status

ANDA Active Since 2008-01-03

Description

NDC 65841-633-01 in bottle of 100 tablets Hydroxychloroquine Sulfate Tablets USP, 200 mg R x only 100 tablets

Medication Information

Description

NDC 65841-633-01 in bottle of 100 tablets Hydroxychloroquine Sulfate Tablets USP, 200 mg R x only 100 tablets

Package Label.principal Display Panel

NDC 65841-633-01 in bottle of 100 tablets

Hydroxychloroquine Sulfate Tablets USP, 200 mg

R_xonly

100 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-633-01 in bottle of 100 tablets

Hydroxychloroquine Sulfate Tablets USP, 200 mg

R_xonly

100 tablets

Advanced Ingredient Data

[{"name": "HYDROXYCHLOROQUINE", "unii": "4QWG6N8QKH", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-633-01 in bottle of 100 tablets Hydroxychloroquine Sulfate Tablets USP, 200 mg R x only 100 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:50:11.433044 · Updated: 2026-03-14T22:36:18.567883