NDC 61786-837-19
API & Excipient Details

Rosuvastatin Calcium marketed by REMEDYREPACK INC. under NDC Code 61786-837-19

NDC Code(s) : 61786-837-19
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosuvastatin CalciumRosuvastatin calcium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61786-837(NDC:16252-618)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	16 mm
Flavor		Imprint Code	RU40
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-837-19	90 in 1 BOTTLE Type 0: Not a Combination Product	22/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079167	08/22/2016

PRINCIPAL DISPLAY PANEL