Mesalamine (Page 5 of 5)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.375 g (120 Capsules Bottle)

NDC 59651-397-08
Rx only
Mesalamine
Extended-Release
Capsules, USP
0.375 g AUROBINDO 120 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.375 g (120 Capsules Bottle)
(click image for full-size original)
MESALAMINE mesalamine capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-397
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 0.375 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SODIUM LAURYL SULFATE
MICROCRYSTALLINE CELLULOSE 101
NONOXYNOL-100
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
DIMETHICONE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
D&C RED NO. 22
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color BLUE (light blue cap, light blue body) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code MSM;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-397-08 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214477 03/31/2023
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650918514 ANALYSIS (59651-397), MANUFACTURE (59651-397)

Revised: 01/2024 Aurobindo Pharma Limited

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