Nexplanon

Nexplanon

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 117494753

Effective Date

September 29, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Etonogestrel(68 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

78206-145

Application Number

NDA021529

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

September 29, 2023

Ingredients

Code: 304GTH6RNHClass: ACTIBQuantity: 68 mg in 1 1

ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE)Inactive

Code: 8ILA5X28VSClass: IACTQuantity: 43 mg in 1 1

BARIUM SULFATEInactive

Code: 25BB7EKE2EClass: IACTQuantity: 15 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACTQuantity: 0.1 mg in 1 1