NDC 50419-422

Skyla

Levonorgestrel

Skyla 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: 50419-422_1af7ccc0-949d-4929-8b82-1fb9184ef914
• NDC: 50419-422
• Product Type: Human Prescription Drug
• Proprietary Name: Skyla
• Generic Name: Levonorgestrel
• Dosage Form: Intrauterine Device
• Route of Administration: INTRAUTERINE
• Marketing Start Date: 2013-01-11
• Marketing Category: NDA / NDA
• Application Number: NDA203159
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: LEVONORGESTREL
• Active Ingredient Strength: 14 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: 2022-12-31

Packaging

NDC 50419-422-01

1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)

• Marketing Start Date: 2013-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-422-08 [50419042208]

Skyla INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA203159
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-11

NDC 50419-422-01 [50419042201]

Skyla INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA203159
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-11

NDC 50419-422-71 [50419042271]

Skyla INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA203159
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-11

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	13.5 mg/1

OpenFDA Data

• SPL SET ID: 9f44ff35-e052-49cd-a1c2-0bfd87d49309
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 1366334
  • 1366339

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
50419-422	Skyla	Levonorgestrel
50102-111	EContra EZ	levonorgestrel
50102-211	EContra One-Step	Levonorgestrel
50419-424	Kyleena	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