NDC Code(s) : 61786-835-19, 61786-835-02
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:61786-835(NDC:16252-616)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
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 ROUND Size 7 mm
Flavor Imprint Code RU10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-835-1990 in 1 BOTTLE Type 0: Not a Combination Product22/08/2016
2NDC:61786-835-0230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 08/22/2016

PRINCIPAL DISPLAY PANEL

DRUG: Rosuvastatin Calcium

GENERIC: Rosuvastatin calcium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-835-19

NDC: 61786-835-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: RU10

PACKAGING: 90 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • ROSUVASTATIN CALCIUM 10mg in 1

INACTIVE INGREDIENT(S):

  • FERRIC OXIDE RED
  • TALC
  • FERRIC OXIDE YELLOW
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • FD&C BLUE NO. 2
  • FD&C RED NO. 40
  • INDIGOTINDISULFONATE SODIUM
  • POLYETHYLENE GLYCOL 4000
  • CROSPOVIDONE, UNSPECIFIED
  • SODIUM CARBONATE MONOHYDRATE
  • LACTOSE MONOHYDRATE
  • SODIUM LAURYL SULFATE
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE
  • MICROCRYSTALLINE CELLULOSE
  • POLYETHYLENE GLYCOL 3500

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