NDC 50419-424

Kyleena

Levonorgestrel

Kyleena is a Intrauterine Intrauterine Device in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Levonorgestrel.

• Product ID: 50419-424_5d263af6-6214-4bb8-8350-9eaa0cabe3ce
• NDC: 50419-424
• Product Type: Human Prescription Drug
• Proprietary Name: Kyleena
• Generic Name: Levonorgestrel
• Dosage Form: Intrauterine Device
• Route of Administration: INTRAUTERINE
• Marketing Start Date: 2016-09-19
• Marketing Category: NDA / NDA
• Application Number: NDA208224
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: LEVONORGESTREL
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50419-424-01

1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)

• Marketing Start Date: 2016-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-424-08 [50419042408]

Kyleena INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA208224
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-19

NDC 50419-424-71 [50419042471]

Kyleena INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA208224
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-19

NDC 50419-424-01 [50419042401]

Kyleena INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA208224
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-19

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	19.5 mg/1

OpenFDA Data

• SPL SET ID: 2e07c155-21e1-4781-9633-ce8bddd47080
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 1811886
  • 1856546

Pharmacological Class

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

NDC Crossover Matching brand name "Kyleena" or generic name "Levonorgestrel"

NDC	Brand Name	Generic Name
50419-424	Kyleena	Levonorgestrel
50102-111	EContra EZ	levonorgestrel
50102-211	EContra One-Step	Levonorgestrel
0536-1142	Levonorgestrel	Levonorgestrel
40032-620	Levonorgestrel	Levonorgestrel
40032-622	Levonorgestrel	Levonorgestrel
40051-054	LEVONORGESTREL	levonorgestrel
49615-017	Levonorgestrel	Levonorgestrel
0023-5858	LILETTA	Levonorgestrel
50419-423	Mirena	Levonorgestrel
43386-620	My Way	Levonorgestrel
43386-622	My Way	Levonorgestrel
16714-809	New Day	levonorgestrel
21695-443	NEXT CHOICE	Levonorgestrel
0113-2003	Option 2	levonorgestrel
21695-973	Plan B One-Step	levonorgestrel
50090-1141	Plan B One-Step	Levonorgestrel
50090-3830	Plan B One-Step	levonorgestrel
50090-5978	Plan B One-Step	levonorgestrel
11509-0067	Preventeza	levonorgestrel
50419-422	Skyla	Levonorgestrel