Mesalamine (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Mesalamine extended-release capsules 120 Capsules, Bottle Label

NDC 68682-113-20

Rx only

MESALAMINE
EXTENDED-RELEASE
CAPSULES
0.375 g

120 Capsules
OCEANSIDE PHARMACEUTICALS

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(click image for full-size original)
MESALAMINE mesalamine capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 375 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
ASPARTAME
ANHYDROUS CITRIC ACID
CROSPOVIDONE, UNSPECIFIED
Product Characteristics
Color BLUE (Light Blue) , BLACK (BLACK) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor VANILLA (VANILLA) Imprint Code G;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68682-113-20 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (68682-113-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022301 07/19/2018
Labeler — Oceanside Pharmaceuticals (832011691)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 829672745 MANUFACTURE (68682-113)
Establishment
Name Address ID/FEI Operations
Carton Service, Incorporated 928861723 PACK (68682-113)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies, Inc. 253292734 MANUFACTURE (68682-113), PACK (68682-113)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 PACK (68682-113), LABEL (68682-113)

Revised: 10/2020 Oceanside Pharmaceuticals

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