Prescription Drug Information: Amethyst (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52544-295-28
Rx Only
Amethyst
(Levonorgestrel and
Ethinyl Estradiol Tablets, USP,
90 mcg/20 mcg)

NDC 52544-295-28 Amethyst (Levongesterel and Ethinyl Estradiol Tabs, USP, 90 mcg/20 mcg) Rx Only
(click image for full-size original)
AMETHYST levonorgestrel and ethinyl estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-295
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 90 ug
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 20 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
POVIDONE K30
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 295;WATSON
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52544-295-28 1 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (52544-295-28) and contains a BLISTER PACK
1 28 TABLET in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (52544-295-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079218 06/13/2011 07/31/2024
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 12/2021 Actavis Pharma, Inc.

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