FDA.reportPublic FDA data

NDC 57664-024-98 - Isotretinoin

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
57664-024
Requested NDC
57664-024-98
Package NDCs from labels
57664-024-98, 57664-024-97
Manufacturer
Sun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc.
Effective date
2024-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IsotretinoinSun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc.2024-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-024-97Isotretinoin3 in 1 BOXCAPSULE32
57664-024-98Isotretinoin10 in 1 BLISTER PACKCAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-024ISOTRETINOIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]2Current NDC, Legacy NDC, 2 package rows20240110_b44200ba-6672-4ea7-b151-7caec3f53c9c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-024-97EA - Each57664-0243dba35f3-b1c6-4e71-a531-0b2b42912ee812021-05-05
57664-024-98EA - Each57664-0247c30c008-9e3b-48a2-be93-cf814b6a5ae212021-05-05

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 92 of 109 · 2,170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8e94e203-d3cf-45a1-88f9-6999f0aab22b2023-12-31WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3d9ed59f-f280-4cc2-a0f1-4180deb5b7922023-12-30WarningsExact identifier
unii: 15FIX9V2JP
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
unii: 15FIX9V2JP
Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incaec1957a-f68d-4fbd-af9e-f8b257daea462023-12-27WarningsExact identifier
unii: 15FIX9V2JP
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.e32233ef-ea15-45b8-8e83-b658cf4c56a02023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Sunmark Lubricant Eye DropsPOLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCb117ff0a-1a48-4022-96e6-52bc45f056fc2023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
unii: 6DC9Q167V3
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fairTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.32569352-c51e-4f05-a8b0-749ef916a5af2023-12-22WarningsExact identifier
unii: 15FIX9V2JP
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc0adb52f5-4e1f-4570-9b6f-584e4da61d9f2023-12-22WarningsExact identifier
unii: 15FIX9V2JP
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCc670635a-63d8-4b0b-afd7-b26e969f93a12023-12-21WarningsExact identifier
unii: 15FIX9V2JP
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
unii: 15FIX9V2JP
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
unii: 15FIX9V2JP
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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