FDA.reportPublic FDA data

Misoprostol

Product NDC
43393-200
11-digit product format
433930200
Labeler code
43393
Product ID
43393-200_2d6ce914-5f86-a393-e063-6294a90a6d9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
GenBioPro, Inc.
Application
ANDA210201
Marketing category
ANDA
Marketing start
2024-09-30
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Misoprostol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43393-200-04Misoprostol4 in 1 BLISTER PACKTABLET42
43393-200-48Misoprostol12 in 1 CARTONTABLET122
43393-200-60Misoprostol60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43393-200-04EA - Each43393-200f02dbdad-93d7-403e-8ac7-17f0eeeaeddc12025-02-10
43393-200-48EA - Each43393-200a275f4af-3801-485c-a54b-04715f95258112025-01-14
43393-200-60EA - Each43393-2004e2f5ec0-5bc1-473d-ae23-fcf7fa31e08812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43393-200MISOPROSTOL TABLET [GENBIOPRO, INC.]2Current NDC, 3 package rows20250207_21e20753-4a67-ce4e-e063-6394a90aa598.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN21e20753-4a67-ce4e-e063-6394a90aa5982
317128misoprostol 0.2 MG Oral TabletSCD21e20753-4a67-ce4e-e063-6394a90aa5982
317128misoprostol 200 MCG Oral TabletSY21e20753-4a67-ce4e-e063-6394a90aa5982
317128miSOPROStol 200 MCG Oral TabletPSN28a4138c-f302-5109-e063-6394a90a94fa1
317128misoprostol 0.2 MG Oral TabletSCD28a4138c-f302-5109-e063-6394a90a94fa1
317128misoprostol 200 MCG Oral TabletSY28a4138c-f302-5109-e063-6394a90a94fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43393-200-04433930200044 in 1 BLISTER PACKHistorical
43393-200-484339302004812 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK (43393-200-04) 12 blister pack2024-09-30NoNoHistorical
43393-200-604339302006060 TABLET in 1 BOTTLE (43393-200-60) 60 tablet2024-09-30NoNoHistorical