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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)

Tilgjengelig fra:

Granules India Limited

Administreringsrute:

NOT APPLICABLE

Autorisasjon status:

Export only

Preparatomtale

MELATONIN RAPID RELEASE GELCAPS 5 MG- MELATONIN RAPID RELEASE
GELCAPS CAPSULE
GRANULES INDIA LIMITED
----------
MELATONIN RAPID RELEASE GELCAPS 5MG
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MELATONIN RAPID RELEASE GELCAPS 5 MG
melatonin rapid release gelcaps capsule
PRODUCT INFORMATION
PRODUCT TYPE
BULK INGREDIENT
ITEM CODE (SOURCE)
NDC:62207-796
ROUTE OF ADMINISTRATION
NOT APPLICABLE
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)
MELATONIN
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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)
Granules India Limited
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
COLOR
white (blue grey opaque and yellow opaque hard gelatin capsules)
SCORE
no score
SHAPE
CAPSULE
SIZE
16mm
FLAVOR
IMPRINT CODE
G20
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1 NDC:62207-796-38
37500 in 1 BOX
08/16/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
Export only
08/16/2017
LABELER -
Granules India Limited (915000087)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Granules India Limited
918609236
manufacture(62207-796)
Revised: 2/2023