SULINDAC (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 200 mg

Sulindac Tablets USP, 200 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 Tablets

Sulindac-200mg-500ct
(click image for full-size original)
SULINDAC
sulindac tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULINDAC (SULINDAC) SULINDAC 150 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K29/32
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code E10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-770-01 100 TABLET in 1 BOTTLE None
2 NDC:24658-770-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072710 11/14/2016
SULINDAC
sulindac tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-771
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULINDAC (SULINDAC) SULINDAC 200 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 14mm
Flavor Imprint Code E11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-771-01 100 TABLET in 1 BOTTLE None
2 NDC:24658-771-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072711 11/14/2016
Labeler — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
Registrant — Epic Pharma, LLC (827915443)
Establishment
Name Address ID/FEI Operations
Epic Pharma, LLC 827915443 manufacture (24658-770), manufacture (24658-771)

Revised: 04/2019 PuraCap Laboratories LLC dba Blu Pharmaceuticals

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