NDC Code(s) : 35356-251-00, 35356-426-30, 35356-249-00, 35356-250-00
Packager : Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Premarinconjugated estrogens TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-251(NDC:0046-1101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED(UNII: IU5QR144QX)
(ESTROGENS, CONJUGATED - UNII:IU5QR144QX) 		ESTROGENS, CONJUGATED0.45 mg
Inactive Ingredients
Ingredient Name Strength
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color BLUE (BLUE) Score no score
Shape OVAL (OVAL) Size 10 mm
Flavor Imprint Code PREMARIN;045
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-251-00100 in 1 BOTTLE Type 0: Not a Combination Product22/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA004782 03/22/2012 12/31/2014
Premarinconjugated estrogens TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-426(NDC:0046-1104)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED(UNII: IU5QR144QX)
(ESTROGENS, CONJUGATED - UNII:IU5QR144QX) 		ESTROGENS, CONJUGATED1.25 mg
Inactive Ingredients
Ingredient Name Strength
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape OVAL (OVAL) Size 14 mm
Flavor Imprint Code PREMARIN;125
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-426-3030 in 1 BOTTLE Type 0: Not a Combination Product22/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA004782 03/22/2012 12/31/2014
Premarinconjugated estrogens TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-249(NDC:0046-1100)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED(UNII: IU5QR144QX)
(ESTROGENS, CONJUGATED - UNII:IU5QR144QX) 		ESTROGENS, CONJUGATED0.3 mg
Inactive Ingredients
Ingredient Name Strength
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color GREEN (GREEN) Score no score
Shape OVAL (OVAL) Size 10 mm
Flavor Imprint Code PREMARIN;03
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-249-00100 in 1 BOTTLE Type 0: Not a Combination Product22/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA004782 03/22/2012 12/31/2014
Premarinconjugated estrogens TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-250(NDC:0046-1103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED(UNII: IU5QR144QX)
(ESTROGENS, CONJUGATED - UNII:IU5QR144QX) 		ESTROGENS, CONJUGATED0.9 mg
Inactive Ingredients
Ingredient Name Strength
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C RED NO. 7(UNII: ECW0LZ41X8)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (OVAL) Size 12 mm
Flavor Imprint Code PREMARIN;09
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-250-00100 in 1 BOTTLE Type 0: Not a Combination Product22/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA004782 03/22/2012 12/31/2014

PRINCIPAL DISPLAY PANEL

Image of .45mg Label

PRINCIPAL DISPLAY PANEL

Image of 1.25mg Label

PRINCIPAL DISPLAY PANEL

Image of 0.3mg Label

PRINCIPAL DISPLAY PANEL

Image of 0.9mg Label