Hydroxychloroquine Sulfate (Page 5 of 5)

Storage

Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep out of the reach of children. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA

Hydroxychloroquine Sulfate

Label ImageLabel Image
HYDROXYCHLOROQUINE SULFATE
hydroxychloroquine sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4659(NDC:69238-1544)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE) HYDROXYCHLOROQUINE SULFATE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code AC54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4659-1 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-4659-2 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:50090-4659-3 12 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210577 05/17/2018
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4659), REPACK (50090-4659)

Revised: 01/2024 A-S Medication Solutions

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