NDC Code(s) : 0591-5438-01, 0591-5438-10, 0591-5454-01
Packager : Watson Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quinidine SulfateQuinidine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5438
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINIDINE SULFATE(UNII: J13S2394HE)
(QUINIDINE - UNII:ITX08688JL) 		QUINIDINE SULFATE200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code DAN;DAN;5438
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-5438-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-5438-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083288 11/24/1976
Quinidine SulfateQuinidine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5454
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINIDINE SULFATE(UNII: J13S2394HE)
(QUINIDINE - UNII:ITX08688JL) 		QUINIDINE SULFATE300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code DAN;DAN;5454
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-5454-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085583 06/09/1981

PRINCIPAL DISPLAY PANEL

NDC 0591-5438-01
Quinidine
Sulfate 
Tablets USP
200 mg
Watson     100 Tablets      Rx only
NDC 0591-5438-01 Quinidine Sulfate Tablets USP 200 mg Watson 100 Tablets Rx only

PRINCIPAL DISPLAY PANEL

NDC 0591-5454-01
Quinidine
Sulfate 
Tablets USP
300 mg
Watson     100 Tablets      Rx only
NDC 0591-5454-01 Quinidine Sulfate Tablets USP 300 mg Watson 100 Tablets Rx only