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 8 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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