NDC 52544-035

LILETTA

Levonorgestrel

LILETTA is a Intrauterine Intrauterine Device in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Levonorgestrel.

• Product ID: 52544-035_683aabaa-6ab7-4d24-aeb2-e1e2bf4fece0
• NDC: 52544-035
• Product Type: Human Prescription Drug
• Proprietary Name: LILETTA
• Generic Name: Levonorgestrel
• Dosage Form: Intrauterine Device
• Route of Administration: INTRAUTERINE
• Marketing Start Date: 2015-02-26
• Marketing End Date: 2020-01-31
• Marketing Category: NDA / NDA
• Application Number: NDA206229
• Labeler Name: Actavis Pharma, 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

Packaging

NDC 52544-035-54

1 POUCH in 1 CARTON (52544-035-54) > 1 INTRAUTERINE DEVICE in 1 POUCH

• Marketing Start Date: 2015-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52544-035-54 [52544003554]

LILETTA INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA206229
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-26
• Marketing End Date: 2020-01-31

NDC 52544-035-11 [52544003511]

LILETTA INTRAUTERINE DEVICE

• Marketing Category: NDA
• Application Number: NDA206229
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-02-03
• Marketing End Date: 2016-02-25

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	52 mg/1

OpenFDA Data

• SPL SET ID: e32358c2-86c6-40b6-b41f-5d38d50cc723
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 1605257
  • 1605252

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0023-5858	LILETTA	Levonorgestrel
52544-035	LILETTA	LILETTA
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
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