FDA.reportPublic FDA data

Misoprostol

Product NDC
70954-443
11-digit product format
709540443
Labeler code
70954
Product ID
70954-443_f271c446-37dd-4a1f-8664-c8ccea4ab1ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA076095
Marketing category
ANDA
Marketing start
2022-04-11
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, 317128

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
70954-443-10Misoprostol60 in 1 BOTTLETABLET604
70954-443-20Misoprostol120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-443-10EA - Each70954-44326639ea6-c5e1-4298-814c-dbe351fd640912022-05-04
70954-443-20EA - Each70954-443091ebfcc-a002-4b15-a98b-c02e3e8bc6e412022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-443MISOPROSTOL TABLET [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20240110_21386aa1-dc51-41c9-8872-dec4c71ebb46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSNc4668066-3d67-487d-9071-f1e504f66499101
311727misoprostol 0.1 MG Oral TabletSCDc4668066-3d67-487d-9071-f1e504f66499101
311727misoprostol 100 MCG Oral TabletSYc4668066-3d67-487d-9071-f1e504f66499101
311727miSOPROStol 100 MCG Oral TabletPSN21386aa1-dc51-41c9-8872-dec4c71ebb464
317128miSOPROStol 200 MCG Oral TabletPSN21386aa1-dc51-41c9-8872-dec4c71ebb464
311727misoprostol 0.1 MG Oral TabletSCD21386aa1-dc51-41c9-8872-dec4c71ebb464
317128misoprostol 0.2 MG Oral TabletSCD21386aa1-dc51-41c9-8872-dec4c71ebb464
311727misoprostol 100 MCG Oral TabletSY21386aa1-dc51-41c9-8872-dec4c71ebb464
317128misoprostol 200 MCG Oral TabletSY21386aa1-dc51-41c9-8872-dec4c71ebb464
311727miSOPROStol 100 MCG Oral TabletPSNe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727miSOPROStol 100 MCG Oral TabletPSN9462d969-d3e5-4e7f-b556-bd647ab28c422
311727miSOPROStol 100 MCG Oral TabletPSN2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c82
317128miSOPROStol 200 MCG Oral TabletPSN9462d969-d3e5-4e7f-b556-bd647ab28c422
317128miSOPROStol 200 MCG Oral TabletPSNe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 0.1 MG Oral TabletSCD9462d969-d3e5-4e7f-b556-bd647ab28c422
311727misoprostol 0.1 MG Oral TabletSCDe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 0.1 MG Oral TabletSCD2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c82
317128misoprostol 0.2 MG Oral TabletSCD9462d969-d3e5-4e7f-b556-bd647ab28c422
317128misoprostol 0.2 MG Oral TabletSCDe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 100 MCG Oral TabletSY9462d969-d3e5-4e7f-b556-bd647ab28c422
311727misoprostol 100 MCG Oral TabletSY2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c82
311727misoprostol 100 MCG Oral TabletSYe0fafb40-74fb-a9df-e053-2995a90a3caa2
317128misoprostol 200 MCG Oral TabletSY9462d969-d3e5-4e7f-b556-bd647ab28c422
317128misoprostol 200 MCG Oral TabletSYe0fafb40-74fb-a9df-e053-2995a90a3caa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-443-107095404431060 TABLET in 1 BOTTLE (70954-443-10) 60 tablet2022-04-110000-00-00NoNoCurrent
70954-443-2070954044320120 TABLET in 1 BOTTLE (70954-443-20) 120 tablet2022-04-110000-00-00NoNoCurrent