NDC Code(s) : 0169-5174-02, 0169-5174-01, 0169-5175-10, 0169-5175-11
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Activellaestradiol and norethindrone acetate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-5174
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL1 mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S) 		NORETHINDRONE ACETATE0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIACETIN(UNII: XHX3C3X673)
COPOVIDONE(UNII: D9C330MD8B)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code NOVO;288
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-5174-021 in 1 CARTON 22/07/2003
128 in 1 DIALPACK Type 0: Not a Combination Product
2NDC:0169-5174-015 in 1 CELLO PACK 22/07/2003
21 in 1 CARTON 22/07/2003
228 in 1 DIALPACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020907 07/22/2003 10/31/2018
Activellaestradiol and norethindrone acetate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-5175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.5 mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S) 		NORETHINDRONE ACETATE0.1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIACETIN(UNII: XHX3C3X673)
HYDROXYPROPYL CELLULOSE (120000 MW)(UNII: UKE75GEA7F)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code NOVO;291
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-5175-101 in 1 CARTON 04/09/2007
128 in 1 DIALPACK Type 0: Not a Combination Product
2NDC:0169-5175-115 in 1 CELLO PACK 04/09/2007
21 in 1 CARTON 04/09/2007
228 in 1 DIALPACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020907 04/09/2007 04/30/2017

PRINCIPAL DISPLAY PANEL

NDC 0169-5174-02

Activella®

(estradiol/norethindrone
acetate) tablets

1 mg/0.5 mg

28 tablets

Activella 1.0 mg/0.5 mg Carton

PRINCIPAL DISPLAY PANEL

NDC 0169-5175-10

Activella®

(estradiol/norethindrone
acetate) tablets

0.5 mg/0.1 mg

28 tablets

Activella 0.5 mg/0.1 mg Carton

PRINCIPAL DISPLAY PANEL

NDC 0169-5174-01

List 517401

(Contains: 5 of NDC 0169-5174-02)

Activella®
(estradiol/norethindroneacetate) tablets

Rx only

1 mg/0.5 mg

5-28 packs

See enclosed information for the patient
including boxed warning.

This package is not child resistant.

Store in a dry place protected from light.

Store at 20°C to 25°C (68°F to 77°F); excursions
permitted to 15°C to 30°C (59°F to 86°F).

Novo Nordisk Inc.
Plainsboro, NJ 08536
1-866-668-6336
www.novonordisk-us.com

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark

Activella 1.0 mg/0.5 mg - 5 Pack

PRINCIPAL DISPLAY PANEL

NDC 0169-5175-11

LIST 517511

(Contains: 5 of NDC 0169-5175-10)

Activella®
(estradiol/norethindroneacetate) tablets

Rx only

0.5 mg/0.1 mg

5-28 packs

See enclosed information for the patient including
boxed warning.

This package is not child resistant.

Store in a dry place protected from light. Store at
20°C to 25°C (68°F to 77°F); excursions permitted to
15°C to 30°C (59°F to 86°F).

Novo Nordisk Inc.
Plainsboro, NJ 08536
1-866-668-6336
www.novonordisk-us.com

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark

Activella 0.5 mg/0.1 mg - 5 Pack