FDA.reportPublic FDA data

NDC 59762-5007-01 - misoprostol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59762-5007
Requested NDC
59762-5007-01
Package NDCs from labels
59762-5007-1, 59762-5007-2, 59762-5007-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Misoprostol TabletsMylan Pharmaceuticals Inc.2026-08-25HUMAN PRESCRIPTION DRUG LABEL
misoprostol - Bryant Ranch PrepackBryant Ranch Prepack2026-06-30HUMAN PRESCRIPTION DRUG LABEL
Misoprostol TabletsPD-Rx Pharmaceuticals, Inc.2023-09-25HUMAN PRESCRIPTION DRUG LABEL
Misoprostol TabletsH.J. Harkins Company, Inc.2012-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-5007-1misoprostol60 in 1 BOTTLETABLET6015
59762-5007-2misoprostol120 in 1 BOTTLETABLET12015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-5007MISOPROSTOL TABLET [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20250525_c4fe14fb-0a43-4c31-9cd6-29eb0d156705.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5007-1EA - Each59762-50072fc7a1b3-980b-43d2-b991-4858f271b2fa12012-07-24
59762-5007-2EA - Each59762-50074fe02fd7-6d64-41dc-a108-b76dbacfd46c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [GREENSTONE LLC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [GREENSTONE LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [GREENSTONE LLC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [GREENSTONE LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [GREENSTONE LLC]7
misoprostolACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
misoprostolACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
MisoprostolMISOPROSTOLProficient Rx LP85410e16-d164-4666-9539-778e2b4dd1382023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: ZF94AP8MEY
MisoprostolMISOPROSTOLGenBioPro, Inc.2f4d6f06-529c-4b54-908a-0db4c18aff672023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
MisoprostolMISOPROSTOLPharmPak, Inc.b07b3dfc-1cb5-484c-be11-8d14c89c794f2022-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLProficient Rx LP33f7db0b-f049-4d2e-abf5-4db97222e1752022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLLupin Pharmaceuticals,Inc.14f73ae3-7d8d-4d10-b668-8bd5adf8032c2020-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
MisoprostolMISOPROSTOLNovel Laboratories, Inc.a46d05a2-5014-40ff-8f1b-9eca1b0aff3a2020-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
9355aee3-c2a5-485f-ae95-cf93bfc0a57fa5e5413d-bc22-4ae1-959b-0eb0430dbd382012-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 9355aee3-c2a5-485f-ae95-cf93bfc0a57f
spl set id: a5e5413d-bc22-4ae1-959b-0eb0430dbd38

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.