NDC 11509-0067

Preventeza

Levonorgestrel

Preventeza is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Combe Incorporated. The primary component is Levonorgestrel.

Product ID11509-0067_d3c3ba4e-82cc-4905-a40b-a02b53e48255
NDC11509-0067
Product TypeHuman Otc Drug
Proprietary NamePreventeza
Generic NameLevonorgestrel
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-02-19
Marketing CategoryANDA / ANDA
Application NumberANDA202334
Labeler NameCombe Incorporated
Substance NameLEVONORGESTREL
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11509-0067-1

1 BLISTER PACK in 1 CARTON (11509-0067-1) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2018-02-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11509-0067-1 [11509006701]

Preventeza TABLET
Marketing CategoryANDA
Application NumberANDA202334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-02-19

Drug Details

Active Ingredients

IngredientStrength
LEVONORGESTREL1.5 mg/1

OpenFDA Data

SPL SET ID:542aa5d6-d107-40ca-99af-ce509d6a90be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2001351
  • 483325
  • NDC Crossover Matching brand name "Preventeza" or generic name "Levonorgestrel"

    NDCBrand NameGeneric Name
    11509-0067Preventezalevonorgestrel
    50102-111EContra EZlevonorgestrel
    50102-211EContra One-StepLevonorgestrel
    50419-424KyleenaLevonorgestrel
    0536-1142LevonorgestrelLevonorgestrel
    40032-620LevonorgestrelLevonorgestrel
    40032-622LevonorgestrelLevonorgestrel
    40051-054LEVONORGESTRELlevonorgestrel
    49615-017LevonorgestrelLevonorgestrel
    0023-5858LILETTALevonorgestrel
    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
    50419-422SkylaLevonorgestrel

    Trademark Results [Preventeza]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREVENTEZA
    PREVENTEZA
    87505566 not registered Live/Pending
    Value Plus Creations, LLC
    2017-06-26

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