NDC 50419-423

Mirena

Levonorgestrel

Mirena 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: 50419-423_1ca26b30-959c-48e6-a52a-967f47530ead
• NDC: 50419-423
• Product Type: Human Prescription Drug
• Proprietary Name: Mirena
• Generic Name: Levonorgestrel
• Dosage Form: Intrauterine Device
• Route of Administration: INTRAUTERINE
• Marketing Start Date: 2009-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA021225
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: LEVONORGESTREL
• Active Ingredient Strength: 52 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 50419-423-01

1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)

• Marketing Start Date: 2014-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-423-08 [50419042308]

Mirena INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA021225
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-08

NDC 50419-423-01 [50419042301]

Mirena INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA021225
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-30

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	52 mg/1

OpenFDA Data

• SPL SET ID: dcbd6aa2-b3fa-479a-a676-56ea742962fc
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 807283
  • 804156

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
50419-423	Mirena	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
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