Misoprostol

Product NDC
64205-161
11-digit product format
642050161
Labeler code
64205
Product ID
64205-161_a16f882c-6e69-4551-ae58-9d53f4a16da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
ReadyMeds
Application
ANDA091667
Marketing category
ANDA
Marketing start
2012-07-25
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
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-161-022019-11-27C16284748780-19855e2a2-36f6-60a7-e053-dbdaa90a05bdMisoprostol Tablets GAVIS Pharmaceuticals, LLC
64205-161-142019-11-27C16284748780-19855e2a2-36f6-60a7-e053-dbdaa90a05bdMisoprostol Tablets GAVIS Pharmaceuticals, LLC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-161-02Misoprostol2 in 1 BOTTLETABLET23
64205-161-14Misoprostol14 in 1 BOTTLETABLET143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [READYMEDS]3
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [READYMEDS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [READYMEDS]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [READYMEDS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-161MISOPROSTOL TABLET [READYMEDS]3Legacy NDC, 2 package rows20140506_476053b4-cf15-4f5b-8aad-1019c3b710da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN476053b4-cf15-4f5b-8aad-1019c3b710da3
317128misoprostol 0.2 MG Oral TabletSCD476053b4-cf15-4f5b-8aad-1019c3b710da3
317128misoprostol 200 MCG Oral TabletSY476053b4-cf15-4f5b-8aad-1019c3b710da3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-161-02642050161022 in 1 BOTTLEHistorical
64205-161-146420501611414 in 1 BOTTLEHistorical