Misoprostol

Product NDC
43393-203
11-digit product format
433930203
Labeler code
43393
Product ID
43393-203_1a89fe3a-2524-4009-b71f-9f50920a914b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
GenBioPro Inc
Application
ANDA091667
Marketing category
ANDA
Marketing start
2013-01-02
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
43393-203-042019-11-27C16284748780-19855d018-db50-cd31-e053-dbdaa90ab51aMisoprostol Tablets GenBioPro, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43393-203-04Misoprostol4 in 1 BOTTLE, PLASTICTABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43393-203-04EA - Each43393-2033e8c85fb-92b9-41a3-89fe-7f117b683cb112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [GENBIOPRO INC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [GENBIOPRO INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [GENBIOPRO INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [GENBIOPRO INC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [GENBIOPRO INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43393-203MISOPROSTOL TABLET [GENBIOPRO INC]1Legacy NDC, 1 package rows20130107_4179736a-1cb2-4661-8c50-3d68ec7f4025.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN4179736a-1cb2-4661-8c50-3d68ec7f40251
317128misoprostol 0.2 MG Oral TabletSCD4179736a-1cb2-4661-8c50-3d68ec7f40251
317128misoprostol 200 MCG Oral TabletSY4179736a-1cb2-4661-8c50-3d68ec7f40251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43393-203-04433930203044 in 1 BOTTLE, PLASTICHistorical