FDA.reportPublic FDA data

NDC 0378-9040-01 - Cystagon

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
0378-9040
Requested NDC
0378-9040-01
Package NDCs from labels
0378-9040-05, 0378-9040-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2021-08-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cystagon - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2021-08-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-9040-05Cystagon500 in 1 BOTTLE, PLASTICCAPSULE50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9040CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 1 package rows20241215_f495b76d-96c6-48e5-8fa3-30a4336628eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9040-01EA - Each0378-90407cd86a97-c44c-461e-97ed-c9125a8c989112013-02-13
0378-9040-05EA - Each0378-9040505a556a-89dd-4bd5-a4e3-e6c8234eea5e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYSTEAMINE BITARTRATEACTIVE INGREDIENTQO84GZ3TSTCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CYSTEAMINEACTIVE MOIETY5UX2SD1KE2CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]5

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 33 of 134 · 2,679 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
sightAESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEASiddha Flower Essences LLCe6a5a50f-873e-4aa0-ad66-ccfa70c75cde2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
mind and memoryAESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEASiddha Flower Essences LLC0d35b9a2-2123-4c14-b0b8-f45f3820ee032025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
unii: 15FIX9V2JP
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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