NDC Code(s) : 0603-7606-02, 0603-7606-15, 0603-7606-48
Packager : Par Pharmaceutical

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gildess 1.5/30norethindrone acetate and ethinyl estradiol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-7606
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S) 		NORETHINDRONE ACETATE1.5 mg
ETHINYL ESTRADIOL(UNII: 423D2T571U)
(ETHINYL ESTRADIOL - UNII:423D2T571U) 		ETHINYL ESTRADIOL0.03 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
RAW SUGAR(UNII: 8M707QY5GH)
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 93;914
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-7606-156 in 1 CARTON 24/07/2012
1NDC:0603-7606-0221 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0603-7606-483 in 1 CARTON 24/07/2012
2NDC:0603-7606-0221 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077075 07/24/2012 03/31/2018

PRINCIPAL DISPLAY PANEL

This is an image of Gildess® 1.5/30 carton.

PRINCIPAL DISPLAY PANEL

This is an image of the Gildess® 1.5/30 sleeve.