FDA.reportPublic FDA data

NDC 51672-1387-08 - Dapsone

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
51672-1387
Requested NDC
51672-1387-08
Package NDCs from labels
51672-1387-2, 51672-1387-3, 51672-1387-8, 51672-1387-08
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dapsone - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1387-2Dapsone30 g in 1 TUBEGEL306
51672-1387-2Dapsone1 in 1 CARTONGEL16
51672-1387-3Dapsone60 g in 1 TUBEGEL606
51672-1387-3Dapsone1 in 1 CARTONGEL16
51672-1387-8Dapsone1 in 1 CARTONGEL16
51672-1387-8Dapsone90 g in 1 TUBEGEL906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1387DAPSONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20250122_97e6444c-1496-4508-9434-8a2a93225e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1387-3GM - Gram51672-138733e53a7e-2c7f-4d50-8165-1c7544452e5812017-11-06
51672-1387-8GM - Gram51672-138715265e32-1da9-4b8d-9a07-871b94a9d4a312017-11-06

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 5 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapsoneDAPSONE GEL, 5%Trupharma, LLC699b6157-3245-43b6-91ee-c86ea262bc832025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 607295
unii: 8W5C518302
DapsoneDAPSONETrupharma, LLC2763bcbb-e249-be2b-e063-6394a90a50152025-09-05Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONEWestminster Pharmaceuticals, LLC7d317576-5edd-4c27-a00d-68b5944c04a82025-08-28Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DapsoneDAPSONEWestminster Pharmaceuticals, LLCd3fc4934-d48b-4a29-9022-0c82bbdad3992025-08-15Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DapsoneDAPSONENORTHSTAR RX LLC91d027f1-cbc6-4066-870b-01b1ddb1f48f2025-07-09Warnings, Adverse reactionsExact identifier
application number: ANDA209506
rxcui: 607295
unii: 8W5C518302
DapsoneDAPSONENORTHSTAR RX LLC51ebcb4d-4368-4748-a6f3-1ec2100fed632025-07-09Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONESun Pharmaceutical Industries, Inc.32fcb7e0-5a6d-4d95-b81c-148012a541122025-07-02Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONESun Pharmaceutical Industries, Inc.97e6444c-1496-4508-9434-8a2a93225e172025-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA209506
ndc (package): 51672-1387-8
ndc (package): 51672-1387-3
ndc (package): 51672-1387-2
ndc (product): 51672-1387
ndc11 (package): 51672138708
rxcui: 607295
spl id: 38e593e2-d4a5-b8dd-e063-6394a90a62c6
spl set id: 97e6444c-1496-4508-9434-8a2a93225e17
unii: 8W5C518302
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
DapsoneDAPSONEMayne Pharma Commercial LLCcbf9e81e-00ef-4218-975e-6a1610b7f1dd2025-06-09Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
dapsoneDAPSONETorrent Pharmaceuticals Limitedf8cffc24-8310-4f21-ae77-7f6ad60955512025-06-05Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DAPSONEDAPSONEAurobindo Pharma Limitedacd33f0b-8563-467a-93db-a119023315282025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 607295
unii: 8W5C518302
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: A2I8C7HI9T
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
DapsoneDAPSONEChartwell RX, LLC93028aff-54f0-4f94-b925-a914001182942025-04-29Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONEAlembic Pharmaceuticals Inc.2811f7de-13bf-45cd-8413-5b04d11f40ff2025-04-03Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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