MELATONIN RAPID RELEASE GELCAPS 5 MG- melatonin rapid release gelcaps capsule 
Granules India Limited

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Melatonin Rapid Release Gelcaps 5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

melatonin-5mg

MELATONIN RAPID RELEASE GELCAPS 5 MG 
melatonin rapid release gelcaps capsule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-796
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SHELLAC (UNII: MB5IUD6JUA)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
AMMONIA (UNII: 5138Q19F1X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Colorwhite (blue grey opaque and yellow opaque hard gelatin capsules) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code G20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-796-3837500 in 1 BOX08/16/201707/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/16/201707/01/2023
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-796)

Revised: 7/2023
 
Granules India Limited