FDA.reportPublic FDA data

NDC 43393-200-04 - 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
43393-200
Requested NDC
43393-200-04
Package NDCs from labels
43393-200-60, 43393-200-04, 43393-200-48
Manufacturer
GenBioPro, Inc.
Effective date
2026-06-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Misoprostol - GenBioPro, Inc.GenBioPro, Inc.2026-06-06HUMAN PRESCRIPTION DRUG LABEL
Misoprostol - GenBioPro, Inc.GenBioPro, Inc.2024-12-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43393-200-04Misoprostol4 in 1 BLISTER PACKTABLET42
43393-200-48Misoprostol12 in 1 CARTONTABLET122
43393-200-60Misoprostol60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43393-200MISOPROSTOL TABLET [GENBIOPRO, INC.]2Current NDC, 3 package rows20250207_21e20753-4a67-ce4e-e063-6394a90aa598.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43393-200-04EA - Each43393-200f02dbdad-93d7-403e-8ac7-17f0eeeaeddc12025-02-10
43393-200-48EA - Each43393-200a275f4af-3801-485c-a54b-04715f95258112025-01-14
43393-200-60EA - Each43393-2004e2f5ec0-5bc1-473d-ae23-fcf7fa31e08812024-12-10

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 · 74 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
application number: ANDA210201
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
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.