MELATONIN RAPID RELEASE GELCAPS 10 MG- melatonin rapid release gelcaps tablet 
Granules India Limited

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Melatonin Rapid Release Gelcaps 10 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

melatonin 10 mg

MELATONIN RAPID RELEASE GELCAPS 10 MG 
melatonin rapid release gelcaps tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-797
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: 46N107B71O)  
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:62207-797-3837500 in 1 BOX08/01/201707/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/01/201707/01/2023
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236manufacture(62207-797)

Revised: 7/2023
Document Id: 01c20d05-ac56-5b88-e063-6294a90a1616
Set id: c6f186b5-dd2d-47d2-b3a2-7382330c3749
Version: 4
Effective Time: 20230731
 
Granules India Limited