FDA.reportPublic FDA data

NDC 68084-040-11 - 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
68084-040
Requested NDC
68084-040-11
Package NDCs from labels
68084-040-11, 68084-040-01
Manufacturer
American Health Packaging
Effective date
2023-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Misoprostol - American Health PackagingAmerican Health Packaging2023-04-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-040-01EA - Each68084-04067d629e4-fb1e-4668-ad00-6080b7f2073b12013-08-02
68084-040-11EA - Each68084-0403404c5d8-e053-4d73-8cc8-07c3b352496b12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]1

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HOUKEA Pure Magnesium OilGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.33fc279b-3b15-973d-e063-6394a90aad3e2025-11-27WarningsExact identifier
unii: ZF94AP8MEY
WastedBENZALKONIUM CHLORIDEFreshorize Ltd0c43b516-7608-c826-e063-6294a90ae4e32025-10-23WarningsExact identifier
unii: ZF94AP8MEY
MisoprostolMISOPROSTOLANI Pharmaceuticals, Inc.21386aa1-dc51-41c9-8872-dec4c71ebb462025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBluePoint Laboratories9a22cb4b-e49a-4bd7-b235-47405c3026582025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
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
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
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
rxcui: 311727
unii: 0E43V0BB57
MisoprostolMISOPROSTOLGenBioPro, Inc.28a4138c-f302-5109-e063-6394a90a94fa2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
MisoprostolMISOPROSTOLNuCare Pharmaceuticals,Inc.8642b8e4-d1bb-f12a-e053-2a91aa0a14bf2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091667
rxcui: 317128
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
rxcui: 317128
unii: 0E43V0BB57
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: ZF94AP8MEY
f92913ff-ba8d-7764-e053-6294a90a7242f902a2a6-0420-4632-a19b-050e40db68032023-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: f92913ff-ba8d-7764-e053-6294a90a7242
spl set id: f902a2a6-0420-4632-a19b-050e40db6803
MisoprostolMISOPROSTOLGenBioPro, Inc.2f4d6f06-529c-4b54-908a-0db4c18aff672023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
MisoprostolMISOPROSTOLPharmPak, Inc.b07b3dfc-1cb5-484c-be11-8d14c89c794f2022-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091667
rxcui: 317128
unii: 0E43V0BB57

Reported adverse events (FAERS/openFDA)#

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