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 31 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cervical Drops 5002CERVICAL DROPSProfessional Complementary Health Formulasedd5f196-1423-4d4c-a8c1-89427c4f387e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 1K09F3G675
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
unii: 15FIX9V2JP
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
unii: 15FIX9V2JP
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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