NDC 12634-502

misoprostol

Misoprostol

misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca Inc.. The primary component is Misoprostol.

Product ID12634-502_477e9a4a-19a9-6846-e054-00144ff88e88
NDC12634-502
Product TypeHuman Prescription Drug
Proprietary Namemisoprostol
Generic NameMisoprostol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA019268
Labeler NameApotheca Inc.
Substance NameMISOPROSTOL
Active Ingredient Strength200 ug/1
Pharm ClassesProstaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-502-00

10 TABLET in 1 BOTTLE (12634-502-00)
Marketing Start Date2009-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-502-52 [12634050252]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-60 [12634050260]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-96 [12634050296]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-93 [12634050293]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-00 [12634050200]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-61 [12634050261]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-94 [12634050294]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-91 [12634050291]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-90 [12634050290]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-84 [12634050284]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-66 [12634050266]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-45 [12634050245]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-95 [12634050295]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-09 [12634050209]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-97 [12634050297]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-40 [12634050240]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-54 [12634050254]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-81 [12634050281]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-57 [12634050257]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-80 [12634050280]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-63 [12634050263]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-78 [12634050278]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-67 [12634050267]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-18 [12634050218]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-69 [12634050269]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-74 [12634050274]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-50 [12634050250]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-12 [12634050212]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-98 [12634050298]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-42 [12634050242]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-82 [12634050282]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-85 [12634050285]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-71 [12634050271]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-59 [12634050259]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-79 [12634050279]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-92 [12634050292]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-01 [12634050201]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

NDC 12634-502-99 [12634050299]

misoprostol TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA019268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-27

Drug Details

Active Ingredients

IngredientStrength
MISOPROSTOL200 ug/1

OpenFDA Data

SPL SET ID:f15b41bd-ed36-4908-aba5-f0a019b7a26e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317128

    • Pharmacological Class

    • Prostaglandin E1 Analog [EPC]
    • Prostaglandins E
    • Synthetic [CS]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.