FDA.reportPublic FDA data

NDC 60505-2575-07 - Balsalazide Disodium

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
60505-2575
Requested NDC
60505-2575-07
Package NDCs from labels
60505-2575-3, 60505-2575-7, 60505-2575-4, 60505-2575-0, 60505-2575-07
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Balsalazide Disodium - Apotex Corp. | Apotex Inc.Apotex Corp. | Apotex Inc.2026-09-09HUMAN PRESCRIPTION DRUG LABEL
Balsalazide Disodium - AvPAKAvPAK2025-12-30HUMAN PRESCRIPTION DRUG LABEL
Balsalazide Disodium - Bryant Ranch PrepackBryant Ranch Prepack2025-04-02HUMAN PRESCRIPTION DRUG LABEL
Balsalazide Disodium - AvKAREAvKARE2022-01-13HUMAN PRESCRIPTION DRUG LABEL
Balsalazide Disodium - Bryant Ranch PrepackBryant Ranch Prepack2021-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2575-0Balsalazide Disodium10 in 1 BLISTER PACKCAPSULE1014
60505-2575-0Balsalazide Disodium10 in 1 CARTONCAPSULE1014
60505-2575-3Balsalazide Disodium30 in 1 BOTTLECAPSULE3014
60505-2575-4Balsalazide Disodium350 in 1 BOTTLECAPSULE35014
60505-2575-7Balsalazide Disodium280 in 1 BOTTLECAPSULE28014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2575BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]14Current NDC, Legacy NDC, 5 package rows20250104_f12ffa32-d14b-e9d9-e957-2ef08b64e8b4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2575-7EA - Each60505-257567293267-eba4-4f49-b576-fa94e3cfd02a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]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 34 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-564f-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 320 CTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c596-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e20c57-7b30-4e96-e053-2991aa0aab3e2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
unii: 15FIX9V2JP
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
unii: 15FIX9V2JP
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

Reported adverse events (FAERS/openFDA)#

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