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 106 of 109 · 2,165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASaa708db4-ad90-49b7-a250-5698e4c7d3d62021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CalicoOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS96437795-906f-4e11-ac69-c0c2ae264aae2021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CashewOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb5527aba-5856-44cd-a1d5-f2d7cefb45ea2021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS9b641ccb-3046-4b21-8164-b80813090cb42021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2500fe73-00e2-47ba-9e2b-1c268ed4a9e62021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS4df1b021-5028-456e-87f2-a96ea6c26c7b2021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS830a485c-53d4-4fa9-b0cd-0fd2a9bd234b2021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8a9fe755-32a2-49b0-8c78-f84bd2ba148f2021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc5f3f1bc-adca-495f-b1bc-51c91d42a4802021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 UberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS64db3a1f-d6c7-4766-a52c-a4b0c39e26332021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 WalnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS582a8244-dab8-4861-9115-2e895a586fb92021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply BronzeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS377405a6-b6c6-4afb-9270-73d9330290542021-07-13WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9f7c8d53-6549-4bac-bbae-a2b73fdf6b052021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS5a22b123-9077-4b8a-ac4c-1bdd475c6ac32021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 CalicoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS4647828c-661d-4ebe-b27e-13d8b89647b82021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASc82f36da-16ce-45f4-9786-2026a359060a2021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 WheatOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS3d86dca5-9e33-4284-a4c1-f5eed64b06202021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 WillowOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS0489a046-2173-4137-abff-c6a7cdb5e8fd2021-07-12WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS58465981-e84c-4eaf-b7d5-fad1666f63fc2021-06-29WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 BambooOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASb2259b27-e1a5-482c-8916-356c1ee9774a2021-06-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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