NDC 0023-5858

LILETTA

Levonorgestrel

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

Product ID0023-5858_0d87a48b-27aa-4ae2-b5bb-8dffe7ddeb34
NDC0023-5858
Product TypeHuman Prescription Drug
Proprietary NameLILETTA
Generic NameLevonorgestrel
Dosage FormIntrauterine Device
Route of AdministrationINTRAUTERINE
Marketing Start Date2020-02-15
Marketing CategoryNDA / NDA
Application NumberNDA206229
Labeler NameAllergan, Inc.
Substance NameLEVONORGESTREL
Active Ingredient Strength52 mg/1
Pharm ClassesInhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0023-5858-01

1 TRAY in 1 CARTON (0023-5858-01) > 1 INTRAUTERINE DEVICE in 1 TRAY
Marketing Start Date2016-05-31
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
LEVONORGESTREL52 mg/1

OpenFDA Data

SPL SET ID:aaf0eb2a-f88a-4f26-a445-0fd30176c326
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0023-5858LILETTALevonorgestrel
    52544-035LILETTALILETTA
    50102-111EContra EZlevonorgestrel
    50102-211EContra One-StepLevonorgestrel
    50419-424KyleenaLevonorgestrel
    0536-1142LevonorgestrelLevonorgestrel
    40032-620LevonorgestrelLevonorgestrel
    40032-622LevonorgestrelLevonorgestrel
    40051-054LEVONORGESTRELlevonorgestrel
    49615-017LevonorgestrelLevonorgestrel
    50419-423MirenaLevonorgestrel
    43386-620My WayLevonorgestrel
    43386-622My WayLevonorgestrel
    16714-809New Daylevonorgestrel
    21695-443NEXT CHOICELevonorgestrel
    0113-2003Option 2levonorgestrel
    21695-973Plan B One-Steplevonorgestrel
    50090-1141Plan B One-StepLevonorgestrel
    50090-3830Plan B One-Steplevonorgestrel
    50090-5978Plan B One-Steplevonorgestrel
    11509-0067Preventezalevonorgestrel
    50419-422SkylaLevonorgestrel

    Trademark Results [LILETTA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LILETTA
    LILETTA
    86608148 4836810 Live/Registered
    ODYSSEA PHARMA SPRL
    2015-04-23
    LILETTA
    LILETTA
    86407620 not registered Dead/Abandoned
    ALLERGAN SALES, LLC
    2014-09-26
    LILETTA
    LILETTA
    85823819 4756366 Live/Registered
    ODYSSEA PHARMA SPRL
    2013-01-15
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