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 75 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
unii: 15FIX9V2JP
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
unii: 15FIX9V2JP
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
unii: 15FIX9V2JP
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 15FIX9V2JP
Ammonia InhalantsAMMONIA INHALANTSDynarex Corporation91e27f1c-0f74-413e-97ff-2fc013f22ca82025-08-11WarningsExact identifier
unii: 5138Q19F1X
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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