Kyleena (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-424-011
Sterile UnitRx only

www.kyleena.com

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

Kyleena

(levonorgestrel-releasing intrauterine system)

— 19.5 mg levonorgestrel

— 1 sterile unit

— intrauterine use

Kyleena Carton
(click image for full-size original)
KYLEENA levonorgestrel intrauterine device
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-424
Route of Administration INTRAUTERINE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 19.5 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
BARIUM SULFATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-424-01 1 INTRAUTERINE DEVICE in 1 CARTON None
2 NDC:50419-424-71 1 INTRAUTERINE DEVICE in 1 CARTON None
3 NDC:50419-424-08 1 INTRAUTERINE DEVICE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208224 09/19/2016
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Bayer Schering Pharma Oy 369758383 MANUFACTURE (50419-424)
Establishment
Name Address ID/FEI Operations
Sharp Corporation 143696495 RELABEL (50419-424), PACK (50419-424), REPACK (50419-424)

Revised: 07/2021 Bayer HealthCare Pharmaceuticals Inc.

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