FDA.reportPublic FDA data

Misoprostol

Product NDC
70954-444
11-digit product format
709540444
Labeler code
70954
Product ID
70954-444_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL200 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
70954-444-10Misoprostol60 in 1 BOTTLETABLET604
70954-444-20Misoprostol100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-444-10EA - Each70954-444d1d35f0a-e053-4acd-8f46-1d727c19345b12022-05-04
70954-444-20EA - Each70954-444a38e0ab8-e557-4b32-a691-241798a0043312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-444MISOPROSTOL 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
317128miSOPROStol 200 MCG Oral TabletPSN51b0bac5-19e3-4547-ba1f-01494fda76879
317128misoprostol 0.2 MG Oral TabletSCD51b0bac5-19e3-4547-ba1f-01494fda76879
317128misoprostol 200 MCG Oral TabletSY51b0bac5-19e3-4547-ba1f-01494fda76879
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
317128miSOPROStol 200 MCG Oral TabletPSN02074b64-64ff-115c-e063-6294a90a8d0b3
317128misoprostol 0.2 MG Oral TabletSCD02074b64-64ff-115c-e063-6294a90a8d0b3
317128misoprostol 200 MCG Oral TabletSY02074b64-64ff-115c-e063-6294a90a8d0b3
311727miSOPROStol 100 MCG Oral TabletPSNe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727miSOPROStol 100 MCG Oral TabletPSN9462d969-d3e5-4e7f-b556-bd647ab28c422
317128miSOPROStol 200 MCG Oral TabletPSNe0fafb40-74fb-a9df-e053-2995a90a3caa2
317128miSOPROStol 200 MCG Oral TabletPSN9462d969-d3e5-4e7f-b556-bd647ab28c422
311727misoprostol 0.1 MG Oral TabletSCDe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 0.1 MG Oral TabletSCD9462d969-d3e5-4e7f-b556-bd647ab28c422
317128misoprostol 0.2 MG Oral TabletSCD9462d969-d3e5-4e7f-b556-bd647ab28c422
317128misoprostol 0.2 MG Oral TabletSCDe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 100 MCG Oral TabletSYe0fafb40-74fb-a9df-e053-2995a90a3caa2
311727misoprostol 100 MCG Oral TabletSY9462d969-d3e5-4e7f-b556-bd647ab28c422
317128misoprostol 200 MCG Oral TabletSYe0fafb40-74fb-a9df-e053-2995a90a3caa2
317128misoprostol 200 MCG Oral TabletSY9462d969-d3e5-4e7f-b556-bd647ab28c422
317128miSOPROStol 200 MCG Oral TabletPSNf05b4562-4301-81dc-e053-2995a90a6b6f1
317128miSOPROStol 200 MCG Oral TabletPSN85410e16-d164-4666-9539-778e2b4dd1381
317128miSOPROStol 200 MCG Oral TabletPSN2f4d6f06-529c-4b54-908a-0db4c18aff671
317128misoprostol 0.2 MG Oral TabletSCD85410e16-d164-4666-9539-778e2b4dd1381
317128misoprostol 0.2 MG Oral TabletSCD2f4d6f06-529c-4b54-908a-0db4c18aff671
317128misoprostol 0.2 MG Oral TabletSCDf05b4562-4301-81dc-e053-2995a90a6b6f1
317128misoprostol 200 MCG Oral TabletSY85410e16-d164-4666-9539-778e2b4dd1381
317128misoprostol 200 MCG Oral TabletSYf05b4562-4301-81dc-e053-2995a90a6b6f1
317128misoprostol 200 MCG Oral TabletSY2f4d6f06-529c-4b54-908a-0db4c18aff671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-444-107095404441060 TABLET in 1 BOTTLE (70954-444-10) 60 tablet2022-04-110000-00-00NoNoCurrent
70954-444-2070954044420100 TABLET in 1 BOTTLE (70954-444-20) 100 tablet2022-04-110000-00-00NoNoCurrent