HYDROXYCHLOROQUINE SULFATE tablet, film coated

Hydroxychloroquine sulfate by

Drug Labeling and Warnings

Hydroxychloroquine sulfate by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 65841-633-01 in bottle of 100 tablets

Hydroxychloroquine Sulfate Tablets USP, 200 mg

Rx only

100 tablets

INGREDIENTS AND APPEARANCE

HYDROXYCHLOROQUINE SULFATE 
hydroxychloroquine sulfate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65841-633
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)	HYDROXYCHLOROQUINE SULFATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OVAL (CAPSULE)	Size	13mm
Flavor		Imprint Code	ZC38
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65841-633-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008
2	NDC: 65841-633-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008
3	NDC: 65841-633-30	10 in 1 CARTON	01/03/2008
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040657	01/03/2008

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Healthcare Limited		918596198	ANALYSIS(65841-633) , MANUFACTURE(65841-633)