FDA.reportPublic FDA data

misoprostol

Product NDC
71335-9631
11-digit product format
713359631
Labeler code
71335
Product ID
71335-9631_4629ba57-842d-45ec-8bf9-a1ed10a0a429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019268
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-12-27
Substance
MISOPROSTOL
Active strength
100 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57
Rxcui311727

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
71335-9631-1misoprostol28 in 1 BOTTLETABLET28101
71335-9631-2misoprostol90 in 1 BOTTLETABLET90101
71335-9631-3misoprostol30 in 1 BOTTLETABLET30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9631-3EA - Each71335-96315f58277c-b062-4763-a569-a19d89460e3612025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9631MISOPROSTOL TABLET [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20231111_c842c35f-6a64-4ecc-95a1-41b6d056047e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSNc842c35f-6a64-4ecc-95a1-41b6d056047e101
311727misoprostol 0.1 MG Oral TabletSCDc842c35f-6a64-4ecc-95a1-41b6d056047e101
311727misoprostol 100 MCG Oral TabletSYc842c35f-6a64-4ecc-95a1-41b6d056047e101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9631-17133596310128 TABLET in 1 BOTTLE (71335-9631-1) 28 tablet2023-01-31NoNoCurrent
71335-9631-27133596310290 TABLET in 1 BOTTLE (71335-9631-2) 90 tablet2023-01-31NoNoCurrent
71335-9631-37133596310330 TABLET in 1 BOTTLE (71335-9631-3) 30 tablet2023-01-31NoNoCurrent