FDA.reportPublic FDA data

Misoprostol 1%

Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-12-17
Label type
BULK INGREDIENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:16

Label at a glance#

ProductMisoprostol 1%
Active ingredientMISOPROSTOL
Label structure1 sections

Label contents#

Full prescribing information#

Misoprostol 1%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

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
73309-265-01Misoprostol 1%1 kg in 1 BAGPOWDER13
73309-265-02Misoprostol 1%0.001 kg in 1 VIALPOWDER0.0013
73309-265-03Misoprostol 1%0.5 kg in 1 BAGPOWDER0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-265MISOPROSTOL 1% POWDER [BLUEBAY SHANDONG CO.,LTD]33 package rows20211218_e13aa73b-8191-429e-91bc-e40aa55ec311.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73309-26573309-265-01, 73309-265-02, 73309-265-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MISOPROSTOL0E43V0BB57ACTIB

Source Document#

Source XML

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 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
misoprostolMISOPROSTOLMylan Pharmaceuticals Inc.c4fe14fb-0a43-4c31-9cd6-29eb0d1567052026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
misoprostolMISOPROSTOLBryant Ranch Prepackc842c35f-6a64-4ecc-95a1-41b6d056047e2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLAmerican Health Packaging9462d969-d3e5-4e7f-b556-bd647ab28c422026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLGenBioPro, Inc.21e20753-4a67-ce4e-e063-6394a90aa5982026-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
CytotecMISOPROSTOLPfizer Laboratories Div Pfizer Inc4ab12da7-5731-4e06-bf1c-bc3f2e711f122026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLBryant Ranch Prepackc4668066-3d67-487d-9071-f1e504f664992026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLPD-Rx Pharmaceuticals, Inc.51b0bac5-19e3-4547-ba1f-01494fda76872026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLAvPAK2396e9c0-3742-69cf-e063-6394a90adb132026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
misoprostolMISOPROSTOLRedpharm Drug2fd197c6-05db-5011-e063-6294a90a585d2025-12-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLANI Pharmaceuticals, Inc.21386aa1-dc51-41c9-8872-dec4c71ebb462025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLNuCare Pharmaceuticals, Inc.2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c82025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLGenBioPro, Inc.28a4138c-f302-5109-e063-6394a90a94fa2024-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLNuCare Pharmaceuticals,Inc.8642b8e4-d1bb-f12a-e053-2a91aa0a14bf2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLProficient Rx LP85410e16-d164-4666-9539-778e2b4dd1382023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLGenBioPro, Inc.2f4d6f06-529c-4b54-908a-0db4c18aff672023-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLPharmPak, Inc.b07b3dfc-1cb5-484c-be11-8d14c89c794f2022-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLLupin Pharmaceuticals,Inc.14f73ae3-7d8d-4d10-b668-8bd5adf8032c2020-12-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL
MisoprostolMISOPROSTOLNovel Laboratories, Inc.a46d05a2-5014-40ff-8f1b-9eca1b0aff3a2020-12-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MISOPROSTOL

Reported adverse events (FAERS/openFDA)#

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