NDC 69189-0161

Misoprostol

Misoprostol

Misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Misoprostol.

Product ID69189-0161_8d27861b-f767-4d46-9472-623919e456b4
NDC69189-0161
Product TypeHuman Prescription Drug
Proprietary NameMisoprostol
Generic NameMisoprostol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA091667
Labeler NameAvera McKennan Hospital
Substance NameMISOPROSTOL
Active Ingredient Strength200 ug/1
Pharm ClassesProstaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69189-0161-1

1 TABLET in 1 DOSE PACK (69189-0161-1)
Marketing Start Date2015-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-0161-1 [69189016101]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-06
Inactivation Date2020-01-31

NDC 69189-0161-4 [69189016104]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MISOPROSTOL200 ug/1

OpenFDA Data

SPL SET ID:aabee26a-3a04-41a1-a0cf-764710a4f6cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317128
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68084-040MisoprostolMisoprostol
    68084-041MisoprostolMisoprostol
    69189-0161MisoprostolMisoprostol
    71335-0460MisoprostolMisoprostol
    55154-4998MisoprostolMisoprostol
    59762-5007misoprostolmisoprostol
    59762-5008misoprostolmisoprostol
    63704-008MisoprostolMisoprostol
    64205-161MisoprostolMisoprostol
    66336-608misoprostolmisoprostol
    68071-4843MisoprostolMisoprostol
    63629-7929MisoprostolMisoprostol
    54348-148MisoprostolMisoprostol
    70710-1007MisoprostolMisoprostol
    70771-1496MisoprostolMisoprostol
    70771-1497MisoprostolMisoprostol
    70710-1006MisoprostolMisoprostol
    72789-121MisoprostolMisoprostol
    72789-111misoprostolmisoprostol
    0025-1451Cytotecmisoprostol
    0025-1461Cytotecmisoprostol
    12634-933CYTOTECMISOPROSTOL

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.