NDC Code(s) : 24658-261-90, 24658-262-90, 24658-262-45, 24658-263-90, 24658-263-45, 24658-264-90, 24658-264-45, 24658-264-30
Packager : PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

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:24658-261
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code 5;B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-261-9090 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207752 08/23/2023
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-262
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code 10;B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-262-9090 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:24658-262-4545 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207752 08/23/2023
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-263
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code 20;B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-263-9090 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:24658-263-4545 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207752 08/23/2023
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-264
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color PINK Score no score
Shape OVAL (biconvex) Size 12 mm
Flavor Imprint Code 40;B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24658-264-9090 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:24658-264-4545 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
3NDC:24658-264-3030 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207752 08/23/2023

LABELER - PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS(080210964)

PRINCIPAL DISPLAY PANEL

5mg-90ct.jpg

PRINCIPAL DISPLAY PANEL

10mg-90ct.jpg

PRINCIPAL DISPLAY PANEL

20mg-45ct.jpg

PRINCIPAL DISPLAY PANEL

40mg-30ct.jpg