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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLSportpharm LLC0d6509a1-7af8-473b-8951-c194392743792026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackde4c02a5-87e8-42f5-a9ff-f409ff9e6d622026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6f9684f7-f39a-4f5e-9fd4-ed140fae206b2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
MisoprostolMISOPROSTOLPD-Rx Pharmaceuticals, Inc.51b0bac5-19e3-4547-ba1f-01494fda76872026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
MisoprostolMISOPROSTOLAvPAK2396e9c0-3742-69cf-e063-6394a90adb132026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
misoprostolMISOPROSTOLRedpharm Drug2fd197c6-05db-5011-e063-6294a90a585d2025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
rxcui: 317128
unii: 0E43V0BB57
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLNivagen Pharmaceuticals, Inc.2acf46ac-8ba8-444d-b421-19d5ad49644c2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
unii: 0E43V0BB57
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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