FDA.reportPublic FDA data

Misoprostol

Product NDC
43386-161
11-digit product format
433860161
Labeler code
43386
Product ID
43386-161_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
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
43386-161-01Misoprostol100 in 1 BOTTLETABLET1006
43386-161-06Misoprostol60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-161-01EA - Each43386-16134655ce2-3024-4c22-b14b-c25a1824832a12013-02-13
43386-161-06EA - Each43386-161a5fb0ebd-625b-495c-9a23-cc83d8feb56812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [READYMEDS]3
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [READYMEDS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [READYMEDS]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [READYMEDS]3
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 [GENBIOPRO INC]1
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [GENBIOPRO INC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [GENBIOPRO INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [GENBIOPRO INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [GENBIOPRO INC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-161MISOPROSTOL 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
317128miSOPROStol 200 MCG Oral TabletPSNfdafd2c5-8c12-4575-a707-bfa7a46cc03c7
317128misoprostol 0.2 MG Oral TabletSCDfdafd2c5-8c12-4575-a707-bfa7a46cc03c7
317128misoprostol 200 MCG Oral TabletSYfdafd2c5-8c12-4575-a707-bfa7a46cc03c7
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
317128miSOPROStol 200 MCG Oral TabletPSNb07b3dfc-1cb5-484c-be11-8d14c89c794f3
317128miSOPROStol 200 MCG Oral TabletPSN476053b4-cf15-4f5b-8aad-1019c3b710da3
317128miSOPROStol 200 MCG Oral TabletPSN8642b8e4-d1bb-f12a-e053-2a91aa0a14bf3
317128misoprostol 0.2 MG Oral TabletSCD476053b4-cf15-4f5b-8aad-1019c3b710da3
317128misoprostol 0.2 MG Oral TabletSCDb07b3dfc-1cb5-484c-be11-8d14c89c794f3
317128misoprostol 0.2 MG Oral TabletSCD8642b8e4-d1bb-f12a-e053-2a91aa0a14bf3
317128misoprostol 200 MCG Oral TabletSY8642b8e4-d1bb-f12a-e053-2a91aa0a14bf3
317128misoprostol 200 MCG Oral TabletSYb07b3dfc-1cb5-484c-be11-8d14c89c794f3
317128misoprostol 200 MCG Oral TabletSY476053b4-cf15-4f5b-8aad-1019c3b710da3
311727miSOPROStol 100 MCG Oral TabletPSN4974780a-ca09-4c1e-b593-bfe17ca084801
317128miSOPROStol 200 MCG Oral TabletPSN4974780a-ca09-4c1e-b593-bfe17ca084801
317128miSOPROStol 200 MCG Oral TabletPSNaabee26a-3a04-41a1-a0cf-764710a4f6cc1
317128miSOPROStol 200 MCG Oral TabletPSN4179736a-1cb2-4661-8c50-3d68ec7f40251
311727misoprostol 0.1 MG Oral TabletSCD4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 0.2 MG Oral TabletSCD4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 0.2 MG Oral TabletSCDaabee26a-3a04-41a1-a0cf-764710a4f6cc1
317128misoprostol 0.2 MG Oral TabletSCD4179736a-1cb2-4661-8c50-3d68ec7f40251
311727misoprostol 100 MCG Oral TabletSY4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 200 MCG Oral TabletSY4974780a-ca09-4c1e-b593-bfe17ca084801
317128misoprostol 200 MCG Oral TabletSYaabee26a-3a04-41a1-a0cf-764710a4f6cc1
317128misoprostol 200 MCG Oral TabletSY4179736a-1cb2-4661-8c50-3d68ec7f40251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-161-0143386016101100 TABLET in 1 BOTTLE (43386-161-01) 100 tablet2012-07-250000-00-00NoNoCurrent
43386-161-064338601610660 TABLET in 1 BOTTLE (43386-161-06) 60 tablet2012-07-250000-00-00NoNoCurrent