NDC Code(s) : 81288-755-90, 81288-755-50, 81288-751-90, 81288-751-50
Packager : EMC PHARMA, LLC

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:81288-755
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
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code LN7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81288-755-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/07/2022
2NDC:81288-755-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207375 07/28/2022
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81288-751
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
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code LN8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81288-751-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/07/2022
2NDC:81288-751-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207375 07/28/2022

LABELER - EMC PHARMA, LLC(117754047)

REGISTRANT - EMC PHARMA, LLC(117754047)

Establishment
Name Address ID/FEI Business Operations
Shandong New Time Pharmaceutical Co., Ltd. 545298254 manufacture(81288-755, 81288-751)

PRINCIPAL DISPLAY PANEL

NDC 81288-755-90
90 tablets
Rosuvastatin Tablets USP, 5 mg
Rx only

image description

PRINCIPAL DISPLAY PANEL

NDC 81288-751-90
90 tablets
Rosuvastatin Tablets USP, 10 mg
Rx only

image description