CYTOTEC

Product NDC
12634-933
11-digit product format
126340933
Labeler code
12634
Product ID
12634-933_51ae34a7-a5eb-47de-8798-60e55a1db305
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc
Application
NDA019268
Marketing category
NDA
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-933-91CYTOTEC1 in 1 BLISTER PACKTABLET11
12634-933-92CYTOTEC2 in 1 BOTTLETABLET21
12634-933-94CYTOTEC4 in 1 BOTTLETABLET41
12634-933-98CYTOTEC8 in 1 BOTTLETABLET81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-933CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]1Legacy NDC, 4 package rows20100405_10644068-fa47-4e3b-9e93-f57ebac3dd17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104098Cytotec 200 MCG Oral TabletPSN10644068-fa47-4e3b-9e93-f57ebac3dd171
317128miSOPROStol 200 MCG Oral TabletPSN10644068-fa47-4e3b-9e93-f57ebac3dd171
104098misoprostol 0.2 MG Oral Tablet [Cytotec]SBD10644068-fa47-4e3b-9e93-f57ebac3dd171
317128misoprostol 0.2 MG Oral TabletSCD10644068-fa47-4e3b-9e93-f57ebac3dd171
104098Cyotec 200 MCG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171
104098Cytotec 0.2 MG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171
317128misoprostol 200 MCG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-933-91126340933911 in 1 BLISTER PACKHistorical
12634-933-92126340933922 in 1 BOTTLEHistorical
12634-933-94126340933944 in 1 BOTTLEHistorical
12634-933-98126340933988 in 1 BOTTLEHistorical