FDA.reportPublic FDA data

Misoprostol

Product NDC
43386-160
11-digit product format
433860160
Labeler code
43386
Product ID
43386-160_b702aa1b-6c21-e44f-e053-2995a90a16f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA091667
Marketing category
ANDA
Marketing start
2012-07-25
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
43386-160-06Misoprostol60 in 1 BOTTLETABLET606
43386-160-12Misoprostol120 in 1 BOTTLETABLET1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-160-06EA - Each43386-1601c49fde3-248a-4f5d-b530-2012db58be7412013-02-13
43386-160-12EA - Each43386-160775610ff-f1b4-424e-b87b-77708ed0a9ce12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [GAVIS PHARMACEUTICALS, LLC]2
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [GAVIS PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [GAVIS PHARMACEUTICALS, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [GAVIS PHARMACEUTICALS, LLC]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [GAVIS PHARMACEUTICALS, LLC]2
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-160MISOPROSTOL TABLET [LUPIN PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20201222_14f73ae3-7d8d-4d10-b668-8bd5adf8032c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSN14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
317128miSOPROStol 200 MCG Oral TabletPSN14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
311727misoprostol 0.1 MG Oral TabletSCD14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
317128misoprostol 0.2 MG Oral TabletSCD14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
311727misoprostol 100 MCG Oral TabletSY14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
317128misoprostol 200 MCG Oral TabletSY14f73ae3-7d8d-4d10-b668-8bd5adf8032c6
311727miSOPROStol 100 MCG Oral TabletPSN7b873139-24ea-41b9-aa93-9f3297d8c7da3
311727misoprostol 0.1 MG Oral TabletSCD7b873139-24ea-41b9-aa93-9f3297d8c7da3
311727misoprostol 100 MCG Oral TabletSY7b873139-24ea-41b9-aa93-9f3297d8c7da3
311727miSOPROStol 100 MCG Oral TabletPSN4974780a-ca09-4c1e-b593-bfe17ca084801
317128miSOPROStol 200 MCG Oral TabletPSN4974780a-ca09-4c1e-b593-bfe17ca084801
311727misoprostol 0.1 MG Oral TabletSCD4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 0.2 MG Oral TabletSCD4974780a-ca09-4c1e-b593-bfe17ca084801
311727misoprostol 100 MCG Oral TabletSY4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 200 MCG Oral TabletSY4974780a-ca09-4c1e-b593-bfe17ca084801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-160-064338601600660 TABLET in 1 BOTTLE (43386-160-06) 60 tablet2012-07-250000-00-00NoNoCurrent
43386-160-1243386016012120 TABLET in 1 BOTTLE (43386-160-12) 120 tablet2012-07-250000-00-00NoNoCurrent