50419-422 : Skyla 13.5 mg/1 Intrauterine Intrauterine Device


NDC50419-422
Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Skyla
Dosage Form: Intrauterine Intrauterine Device
Application #: NDA203159
Rev. Date: 


NDC Package Codes:

  • 50419-422-01: 1 INTRAUTERINE DEVICE IN 1 CARTON (50419‑422‑01)
  • 50419-422-08: 1 INTRAUTERINE DEVICE IN 1 CARTON (50419‑422‑08)
  • 50419-422-71: 1 INTRAUTERINE DEVICE IN 1 CARTON (50419‑422‑71)

Active Ingredients:

  • Levonorgestrel

Dosage Strength:

  • 13.5 mg

Pharmaceutical Classes:

  • Inhibit Ovum Fertilization [PE]
  • Progesterone Congeners [CS]
  • Progestin [EPC]
  • Progestin-containing Intrauterine Device [EPC]

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