NDC Code(s) : 50419-421-01
Packager : Bayer HealthCare Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MirenaLevonorgestrel INTRAUTERINE DEVICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-421
Route of Administration INTRAUTERINE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL(UNII: 5W7SIA7YZW)
(LEVONORGESTREL - UNII:5W7SIA7YZW) 		LEVONORGESTREL52 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
BARIUM SULFATE(UNII: 25BB7EKE2E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50419-421-011 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021225 10/01/2009

PRINCIPAL DISPLAY PANEL

Mirena (levonorgestrel-releasing intrauterine system) Carton

NDC 50419-421-01

1 Sterile Unit

IMPORTANT: To be inserted in the uterus by
or under the supervision of a licensed clinician.
See physician insert for detailed instructions
for use.

Mirena
(levonorgestrel-releasing intrauterine system)

Rx only

— 52 mg levonorgestrel

— 1 sterile unit

— intrauterine use

Mirena Carton