FDA.reportPublic FDA data

NDC 59762-0028-01 - Diclofenac sodium and 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
59762-0028
Requested NDC
59762-0028-01
Package NDCs from labels
59762-0028-1, 59762-0028-2, 59762-0028-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac sodium and Misoprostol - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2026-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0028-1Diclofenac sodium and Misoprostol60 in 1 BOTTLETABLET, FILM COATED6023
59762-0028-2Diclofenac sodium and Misoprostol90 in 1 BOTTLETABLET, FILM COATED9023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0028DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 2 package rows20250524_a7701e8c-4e16-4165-8b83-de2c08d5ded3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0028-1EA - Each59762-002801792c5c-3afb-4df4-9be4-e10a98d6524d12013-02-13
59762-0028-2EA - Each59762-00288062a000-dd36-400c-a3e2-43df6bb95b6912013-02-13
59762-0028-4EA - Each59762-0028f6d32a7d-4427-427f-8725-b9972eab148912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7

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 52 · 1,031 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.5a852412-69af-6502-e063-6294a90a07482026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMYYBA CORP533653e8-93d5-9080-e063-6394a90a165b2026-09-01WarningsExact identifier
unii: QTG126297Q
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020607
ndc (package): 59762-0028-1
ndc (package): 59762-0029-1
ndc (package): 59762-0028-2
ndc (product): 59762-0028
ndc (product): 59762-0029
ndc11 (package): 59762002801
rxcui: 1359105
rxcui: 857706
spl id: 354b9b31-a5f4-4f05-b476-2759945ed43e
spl set id: a7701e8c-4e16-4165-8b83-de2c08d5ded3
unii: QTG126297Q
unii: 0E43V0BB57
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359105
rxcui: 857706
unii: QTG126297Q
unii: 0E43V0BB57
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
misoprostolMISOPROSTOLMylan Pharmaceuticals Inc.c4fe14fb-0a43-4c31-9cd6-29eb0d1567052026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC5990259d-2f90-20d3-e063-6394a90a3d232026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
AMAZON BASIC CARE ARTHRITIS PAINDICLOFENAC SODIUMAmazon.com Services LLC113e2f87-c408-3e44-e063-6394a90a0a7f2026-08-20WarningsExact identifier
unii: QTG126297Q
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC4dde6e36-7540-1cc3-e063-6294a90a39412026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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