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 41 of 134 · 2,679 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
unii: 15FIX9V2JP
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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