NDC Code(s) : 52544-276-21, 52544-290-21, 52544-249-28, 52544-233-28
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MicrogestinNorethindrone Acetate and Ethinyl Estradiol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-276
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 mg
ETHINYL ESTRADIOL(UNII: 423D2T571U)
(ETHINYL ESTRADIOL - UNII:423D2T571U) 		ETHINYL ESTRADIOL0.02 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
SUGARCANE(UNII: 81H2R5AOH3)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code PD;915
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-276-216 in 1 CARTON
121 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
NDA AUTHORIZED GENERIC NDA017876 08/18/2014
MicrogestinNorethindrone Acetate and Ethinyl Estradiol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-290
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
ACACIA(UNII: 5C5403N26O)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
SUGARCANE(UNII: 81H2R5AOH3)
TALC(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code PD;915
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-290-216 in 1 CARTON
121 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
NDA AUTHORIZED GENERIC NDA017875 08/07/2014
MicrogestinNorethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-249
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-249-286 in 1 CARTON
11 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
NDA AUTHORIZED GENERIC NDA017354 09/16/2014
MicrogestinNorethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-233
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-233-286 in 1 CARTON
11 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
NDA AUTHORIZED GENERIC NDA017355 09/12/2014

PRINCIPAL DISPLAY PANEL

NDC 52544-276-21
MICROGESTIN ®1/20
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP)

Microgestin 1/20 Carton

PRINCIPAL DISPLAY PANEL

NDC 52544-249-28
MICROGESTIN® Fe 1/20
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP and Ferrous Fumarate Tablets*)
*ferrous fumarate tablets are not USP for dissolution and assay

Microgestin Fe 1/20 Carton

PRINCIPAL DISPLAY PANEL

NDC 52544-290-21
MICROGESTIN® 1.5/30
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP)

Microgestin 1.5/30 Carton

PRINCIPAL DISPLAY PANEL

NDC 52544-233-28
MICROGESTIN® Fe 1.5/30
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP and Ferrous Fumarate Tablets*)
*ferrous fumarate tablets are not USP for dissolution and assay

Microgestin Fe 1.5/30 Cart5on