Mesalamine (Page 5 of 5)

Package/Label Display Panel

Once-Daily Mesalamine

Delayed-Release Tablets

1.2 g

30 Tablets

Carton label
(click image for full-size original)
MESALAMINE mesalamine tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6832(NDC:68382-711)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 1.2 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color RED (BROWN) Score no score
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code 711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6832-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-6832-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091640 06/19/2017
Labeler — Major Pharmaceuticals (191427277)

Revised: 05/2022 Major Pharmaceuticals

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