NDC 50458-197

Ortho Cyclen

Norgestimate And Ethinyl Estradiol

Ortho Cyclen is a Kit in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is .

Product ID50458-197_3ef3583e-7ea6-11e8-9064-c3969d46d017
NDC50458-197
Product TypeHuman Prescription Drug
Proprietary NameOrtho Cyclen
Generic NameNorgestimate And Ethinyl Estradiol
Dosage FormKit
Marketing Start Date1989-12-29
Marketing CategoryNDA / NDA
Application NumberNDA019653
Labeler NameJanssen Pharmaceuticals, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50458-197-06

6 BLISTER PACK in 1 CARTON (50458-197-06) > 1 KIT in 1 BLISTER PACK (50458-197-28)
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-197-20 [50458019720]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1989-12-29
Marketing End Date2018-02-28

NDC 50458-197-06 [50458019706]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-12-29
Marketing End Date2019-07-30

NDC 50458-197-12 [50458019712]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-12-29
Marketing End Date2019-05-31

NDC 50458-197-00 [50458019700]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-13

NDC 50458-197-28 [50458019728]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-02

NDC 50458-197-15 [50458019715]

Ortho Cyclen KIT
Marketing CategoryNDA
Application NumberNDA019653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-12-29
Marketing End Date2019-03-31

Drug Details

OpenFDA Data

SPL SET ID:384e7a40-dcbd-4908-bf5e-65abc9932973
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 748797
  • 749861
  • 240128
  • 406396
  • 749785
  • 749784
  • 749860
  • 687424

    • Medicade Reported Pricing

    50458019728 ORTHO-CYCLEN 28 TABLET

    Pricing Unit: EA | Drug Type:

    50458019715 ORTHO-CYCLEN 28 TABLET

    Pricing Unit: EA | Drug Type:

    50458019712 ORTHO-CYCLEN 28 TABLET

    Pricing Unit: EA | Drug Type:

    50458019706 ORTHO-CYCLEN 28 TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Ortho Cyclen" or generic name "Norgestimate And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    50458-197Ortho CyclenOrtho Cyclen
    0781-4058EstaryllaNorgestimate and ethinyl estradiol
    16714-360Mono-Linyahnorgestimate and ethinyl estradiol
    0378-7286NORGESTIMATE AND ETHINYL ESTRADIOLnorgestimate and ethinyl estradiol
    0378-7293NORGESTIMATE AND ETHINYL ESTRADIOLnorgestimate and ethinyl estradiol
    17478-260Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl Estradiol
    17478-261Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl Estradiol
    42291-553Norgestimate and Ethinyl EstradiolNorgestimate and ethinyl estradiol
    42291-565Norgestimate and Ethinyl Estradiolnorgestimate and ethinyl estradiol
    42291-590norgestimate and ethinyl estradiolnorgestimate and ethinyl estradiol
    50090-2259Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl Estradiol
    0254-2029PrevifemNorgestimate and ethinyl estradiol
    0603-7642Previfemnorgestimate and ethinyl estradiol
    0555-9016SprintecNorgestimate and Ethinyl Estradiol
    21695-769SprintecNorgestimate and Ethinyl Estradiol
    0781-4060Tri-Estaryllanorgestimate and ethinyl estradiol
    16714-363Tri-LinyahNorgestimate and Ethinyl Estradiol
    0781-4062Tri-Lo- Estaryllanorgestimate and ethinyl estradiol
    50090-2429TRI-LO-MARZIAnorgestimate and ethinyl estradiol
    0093-2140Tri-Lo-SprintecNorgestimate and Ethinyl Estradiol
    50090-2326Tri-Lo-SprintecNorgestimate and Ethinyl Estradiol
    0254-2030Tri-Previfemnorgestimate and ethinyl estradiol
    0603-7663Tri-Previfemnorgestimate and ethinyl estradiol
    0555-9018Tri-Sprintecnorgestimate and ethinyl estradiol
    21695-770Tri-Sprintecnorgestimate and ethinyl estradiol
    21695-407TriNessaNorgestimate and Ethinyl Estradiol
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