NDC Code(s) : 27808-156-01, 27808-156-03, 27808-157-01, 27808-157-03, 27808-158-03, 27808-158-01, 27808-155-01, 27808-155-03
Packager : Tris Pharma Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-156
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code CY;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-156-0190 in 1 BOTTLE Type 0: Not a Combination Product01/08/2018
2NDC:27808-156-03500 in 1 BOTTLE Type 0: Not a Combination Product26/07/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207408 01/08/2018
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code CY;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-157-0190 in 1 BOTTLE Type 0: Not a Combination Product01/08/2018
2NDC:27808-157-03500 in 1 BOTTLE Type 0: Not a Combination Product26/07/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207408 01/08/2018
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code CY;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-158-03500 in 1 BOTTLE Type 0: Not a Combination Product26/07/2019
2NDC:27808-158-0130 in 1 BOTTLE Type 0: Not a Combination Product01/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207408 01/08/2018
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-155
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code CY;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-155-0190 in 1 BOTTLE Type 0: Not a Combination Product01/08/2018
2NDC:27808-155-03500 in 1 BOTTLE Type 0: Not a Combination Product26/07/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207408 01/08/2018

LABELER - Tris Pharma Inc(947472119)

Establishment
Name Address ID/FEI Business Operations
Changzhou Pharmaceutical Factory 653881060 analysis(27808-155, 27808-156, 27808-157, 27808-158), label(27808-155, 27808-156, 27808-157, 27808-158), manufacture(27808-155, 27808-156, 27808-157, 27808-158), pack(27808-155, 27808-156, 27808-157, 27808-158)

PRINCIPAL DISPLAY PANEL

NDC 27808-155-01

Rosuvastatin Calcium Tablets

5 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

90 Tablets

5 mg 90 Tablets5 mg 90 Tablets

NDC 27808-155-03

Rosuvastatin Calcium Tablets

5 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

500 Tablets

5 mg 90 Tablets

NDC 27808-156-01

Rosuvastatin Calcium Tablets

10 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

90 Tablets

5 mg 90 Tablets10 mg 90 Tablets

 

NDC 27808-156-03

Rosuvastatin Calcium Tablets

10 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

500 Tablets

5 mg 90 Tablets

 

NDC 27808-157-01

Rosuvastatin Calcium Tablets

20 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

90 Tablets

5 mg 90 Tablets20 mg 90 Tablets

NDC 27808-157-03

Rosuvastatin Calcium Tablets

20 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

500 Tablets

5 mg 90 Tablets



NDC 27808-158-01

Rosuvastatin Calcium Tablets

40 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

30 Tablets

5 mg 90 Tablets40 mg 30 Tablets

NDC 27808-158-03

Rosuvastatin Calcium Tablets

40 mg

WARNING:
As with all medications, keep out of the reach of children.

Rx only 

500 Tablets

5 mg 90 Tablets