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 39 of 134 · 2,679 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral RichTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0a647c9a-2c71-4cd2-9503-e9ab96b857ee2025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeepTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf246553e-17c2-4dba-855b-1942646bb8342025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep BronzeTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC15de58a4-e2bc-425b-b50b-df2d87dd3bb42025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf493c3ea-41b3-4625-84a6-fab545a769402025-12-18WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
unii: 15FIX9V2JP
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
unii: 15FIX9V2JP
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
unii: 15FIX9V2JP
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
unii: 15FIX9V2JP
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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