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 53 of 110 · 2,196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Perfecting Makeup Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc0a506f55-ea6c-44d3-bab2-0a5875c437572025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inccd4da670-ad26-445e-a243-1e88b54d33352025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc6a6b8780-a11a-4602-aab4-1925d64f786e2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc748a9d28-8814-4394-ad7d-0d6ba868b0bc2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Lasting Foundation SPF 12 Merle NormanTITANIUM DIOXIDEMerle Norman Cosmetics, Incd31cfc74-7dcf-4af1-ba53-63fcad4144642025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.e12f5324-ed27-4a2e-bf49-f39f7fe351cb2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.3a30b330-7f5f-4a8e-b8bc-1cfaad72f9852025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 L10 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.c892e067-5a79-4903-a1f8-d5a9962c1d5c2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.0ad4ec84-7c82-4ab3-9070-a0764af123062025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF15 L20 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.4a08acf3-41e9-4021-9f4b-99a1fd86b2ec2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incdeaa0035-d030-4831-b2be-8b8bba5d8f552025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.02a4e8f6-f257-4d30-8782-64b4d1622d462025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
IntralipidI.V. FAT EMULSIONFresenius Kabi USA, LLC61e025f1-a38e-4af2-9e18-13ea12977cf52025-11-19Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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