FDA.reportPublic FDA data

NDC 60505-2575-03 - 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
60505-2575-03
Package NDCs from labels
60505-2575-3, 60505-2575-7, 60505-2575-4, 60505-2575-0, 60505-2575-03
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 135 of 136 · 2,717 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
First Aid Only Ammonia InhalantsAMMONIA INHALANTSAcme United Corporation6595a2a5-f2d7-85cf-e053-2991aa0a9b522018-02-19WarningsExact identifier
unii: 5138Q19F1X
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
unii: 15FIX9V2JP
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TawnyZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc94d604d4-b0bf-4f3e-888c-b6104241925b2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CocoaZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc9f6a5740-174c-4244-b291-6ab6367ce5122017-12-05WarningsExact identifier
unii: 15FIX9V2JP
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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