Nexplanon: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 68 mg Implant Blister Pack Carton

NDC 78206-145-01
1 applicator containing 1 subdermal implant

Nexplanon®
(etonogestrel implant) 68 mg
Radiopaque
Subdermal Use Only

This product is intended to prevent pregnancy. It does not protect
against HIV infection (AIDS) and other sexually transmitted diseases. Rx only

PRINCIPAL DISPLAY PANEL -- 68 mg Implant Blister Pack Carton
(click image for full-size original)
NEXPLANON etonogestrel implant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-145
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETONOGESTREL (ETONOGESTREL) ETONOGESTREL 68 mg
Inactive Ingredients
Ingredient Name Strength
BARIUM SULFATE 15 mg
MAGNESIUM STEARATE 0.1 mg
ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE) 43 mg
Product Characteristics
Color WHITE (white/off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-145-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 IMPLANT in 1 BLISTER PACK This package is contained within the CARTON (78206-145-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021529 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 11/2022 Organon LLC

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