FDA.reportPublic FDA data

NDC 68308-573-01 - 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
68308-573
Requested NDC
68308-573-01
Package NDCs from labels
68308-573-01, 68308-573-30
Manufacturer
Mayne Pharma
Effective date
2022-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Mayne PharmaMayne Pharma2022-11-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-573-01Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
68308-573-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-573ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]2Current NDC, Legacy NDC, 2 package rows20221105_ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-573-01EA - Each68308-57398e6dc83-393d-4374-9504-6be214fc07d012021-10-08
68308-573-30EA - Each68308-5730581fd12-3ad3-4a3d-bcab-00cb2a94c5f012021-10-08

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 82 of 128 · 2,546 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
unii: 15FIX9V2JP
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Beautyturess Collagen Moisturizing Firming 14-Piece SetBEAUTYTURESS COLLAGEN MOISTURIZING FIRMING 14-PIECE SETGuangdong Bisutang Biotechnology Co., Ltd.2bc94a8a-effb-8319-e063-6394a90a535d2025-01-15WarningsExact identifier
unii: PDC6A3C0OX
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
unii: 15FIX9V2JP
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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