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 127 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: ETJ7Z6XBU4
BB Broad Spectrum SPF 15 LightZINC OXIDE TITANIUM DIOXIDEBurt's Bees3150ef71-2ea1-25d0-e054-00144ff88e882023-10-05WarningsExact identifier
unii: 15FIX9V2JP
BB Broad Spectrum SPF 15 MediumZINC OXIDE TITANIUM DIOXIDEBurt's Bees3346f41e-32d0-35d0-e054-00144ff88e882023-10-05WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
unii: 15FIX9V2JP
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC756cb656-2f79-4e7f-b4b3-18d6e89309212023-10-05WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01TITANIUM DIOXIDEOrveon Global US, LLCf083af9e-e235-5f03-e053-2a95a90a53252023-10-04WarningsExact identifier
unii: 15FIX9V2JP
Fair Foundation SPF 15ZINC OXIDE, TITANIUM DIOXIDEOrveon Global US, LLC491a5768-1aad-458e-b4d6-72ea085d1d9f2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2TITANIUM DIOXIDEOrveon Global US LLC6845acee-5a3f-4c8d-9386-8823b30373f32023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01TITANIUM DIOXIDEOrveon Global US, LLC798934af-f011-4a95-bdb6-b577154713c42023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep MahoganyTITANIUM DIOXIDEOrveon Global US LLCf03b4fa3-4da9-5e44-e053-2a95a90af3442023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5TITANIUM DIOXIDEOrveon Global US LLC2de76f3c-b438-47ca-84e5-e871e9d995a42023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair IvoryTITANIUM DIOXIDEOrveon Global US LLC15c92bce-75f4-40e3-ae28-9bcbc241c8e92023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft RadianceTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC0c2db44d-8604-4883-ab01-f14bc441e4e42023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3c35fd13-1a4b-4acf-ada4-16ee2e52dd942023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 MediumTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3cc5b952-4619-4395-97c0-5b68efa9af6d2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC29c25bc3-902a-41af-996a-8c7e8a4bf5742023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03TITANIUM DIOXIDEOrveon Global US LLCb2909888-5a98-4894-a895-230aa53f64d92023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCa5888955-f381-4209-9589-bd2e79a84f592023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCad15bdee-67e6-4281-8144-e84b7c478a342023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCaa4d7945-6cc9-4f20-b588-a5588e57d30a2023-10-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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