FDA.reportPublic FDA data

NDC 59762-5007-02 - 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
59762-5007-02
Package NDCs from labels
59762-5007-1, 59762-5007-2, 59762-5007-02
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 1 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
misoprostolMISOPROSTOLMylan Pharmaceuticals Inc.c4fe14fb-0a43-4c31-9cd6-29eb0d1567052026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
ndc (package): 59762-5007-2
ndc (package): 59762-5007-1
ndc (package): 59762-5008-2
ndc (package): 59762-5008-1
ndc (product): 59762-5007
ndc (product): 59762-5008
ndc11 (package): 59762500702
rxcui: 311727
rxcui: 317128
spl id: a2441a04-9c20-452a-91e2-025ad1657568
spl set id: c4fe14fb-0a43-4c31-9cd6-29eb0d156705
unii: 0E43V0BB57
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
misoprostolMISOPROSTOLBryant Ranch Prepackc842c35f-6a64-4ecc-95a1-41b6d056047e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
ndc (package): 71335-9631-3
ndc (package): 71335-9631-1
ndc (package): 71335-9631-2
ndc (product): 71335-9631
rxcui: 311727
spl id: e3b5ce1e-3a29-480b-98a1-4f7bb0af7ad7
spl set id: c842c35f-6a64-4ecc-95a1-41b6d056047e
unii: 0E43V0BB57
MisoprostolMISOPROSTOLAmerican Health Packaging9462d969-d3e5-4e7f-b556-bd647ab28c422026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
MisoprostolMISOPROSTOLGenBioPro, Inc.21e20753-4a67-ce4e-e063-6394a90aa5982026-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
CytotecMISOPROSTOLPfizer Laboratories Div Pfizer Inc4ab12da7-5731-4e06-bf1c-bc3f2e711f122026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
unii: ZF94AP8MEY
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6865a5cf-3263-44b5-96d9-7a7a4c6e1c052026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLBryant Ranch Prepackc4668066-3d67-487d-9071-f1e504f664992026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
unii: 0E43V0BB57
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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