NDC 55289-248

Cytotec

Misoprostol

Cytotec is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Misoprostol.

Product ID55289-248_7d39998d-03aa-6e34-e053-2a91aa0a582b
NDC55289-248
Product TypeHuman Prescription Drug
Proprietary NameCytotec
Generic NameMisoprostol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1986-12-27
Marketing CategoryNDA / NDA
Application NumberNDA019268
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameMISOPROSTOL
Active Ingredient Strength100 ug/1
Pharm ClassesProstaglandin E
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-248-28

28 TABLET in 1 BOTTLE, PLASTIC (55289-248-28)
Marketing Start Date2011-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-248-28 [55289024828]

Cytotec TABLET
Marketing CategoryNDA
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-03-11

Drug Details

Active Ingredients

IngredientStrength
MISOPROSTOL100 ug/1

OpenFDA Data

SPL SET ID:5f6565b7-3d3e-4f5b-bf92-8d9f8002a36a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311727
  • 209177
    • UPC Code
  • 0355289248286

    • Pharmacological Class

    • Prostaglandin E1 Analog [EPC]
    • Prostaglandins E
    • Synthetic [CS]

    NDC Crossover Matching brand name "Cytotec" or generic name "Misoprostol"

    NDCBrand NameGeneric Name
    0025-1451Cytotecmisoprostol
    0025-1461Cytotecmisoprostol
    12634-933CYTOTECMISOPROSTOL
    55289-248CytotecCytotec
    0179-0218MisoprostolMisoprostol
    0904-6806MisoprostolMisoprostol
    0904-6807MisoprostolMisoprostol
    10135-745MisoprostolMisoprostol
    10135-746MisoprostolMisoprostol
    12634-502misoprostolMISOPROSTOL
    33261-076MisoprostolMisoprostol
    33261-754MisoprostolMisoprostol
    40032-160MisoprostolMisoprostol
    40032-161MisoprostolMisoprostol
    42571-253MISOPROSTOLMisoprostol
    42571-254MISOPROSTOLMisoprostol
    43063-707MisoprostolMisoprostol
    43386-160MisoprostolMisoprostol
    43386-161MisoprostolMisoprostol
    43393-020misoprostolMISOPROSTOL
    43393-022MisoprostolMisoprostol
    43393-023MisoprostolMisoprostol
    43393-203MisoprostolMisoprostol
    50436-3172MisoprostolMisoprostol
    52959-692misoprostolmisoprostol

    Trademark Results [Cytotec]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYTOTEC
    CYTOTEC
    73474721 1330479 Live/Registered
    Searle & Co.
    1984-04-10
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