FDA.reportPublic FDA data

NDC 73309-265 - Misoprostol 1%

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
73309-265
Package NDCs from labels
73309-265-01, 73309-265-02, 73309-265-03
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Misoprostol 1% - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2021-12-17BULK INGREDIENT

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

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARTHROTECDICLOFENAC SODIUM AND MISOPROSTOLPfizer Laboratories Div Pfizer Inc600fe842-45d9-4d68-9ef2-456dbbebaa112025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLMicro Labs Limitedc61df58d-d6bb-4d3e-9ef8-60caa7d4e7622025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLBryant Ranch Prepack7225385c-501c-4e90-8948-8617d583108c2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAmneal Pharmaceuticals LLCafd30051-8f59-474b-9972-962a5a871dfb2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackd6671b66-00ad-4949-b51a-36e1130b1cb52025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLNuCare Pharmaceuticals, Inc.2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c82025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLGenBioPro, Inc.28a4138c-f302-5109-e063-6394a90a94fa2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLNuCare Pharmaceuticals,Inc.8642b8e4-d1bb-f12a-e053-2a91aa0a14bf2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac sodium and Misoprostol DRDICLOFENAC SODIUM AND MISOPROSTOLAdvanced Rx Pharmacy of Tennessee, LLC1213d3eb-9870-f144-e063-6394a90a60882024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
DICLOENAC SODIUM and MISOPROSTOL DRDICLOENAC SODIUM AND MISOPROSTOLAdvanced Rx Pharmacy of Tennessee, LLCf4d8c198-63e1-3109-e053-2995a90acad92024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLProficient Rx LP85410e16-d164-4666-9539-778e2b4dd1382023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLGenBioPro, Inc.2f4d6f06-529c-4b54-908a-0db4c18aff672023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLPharmPak, Inc.b07b3dfc-1cb5-484c-be11-8d14c89c794f2022-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: 0E43V0BB57
MisoprostolMISOPROSTOLNovel Laboratories, Inc.a46d05a2-5014-40ff-8f1b-9eca1b0aff3a2020-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57

Reported adverse events (FAERS/openFDA)#

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