FDA.reportPublic FDA data

NDC 68308-784-01 - 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
68308-784
Requested NDC
68308-784-01
Package NDCs from labels
68308-784-01, 68308-784-30
Manufacturer
Mayne Pharma
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Mayne PharmaMayne Pharma2024-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-784-01Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
68308-784-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-784ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]4Current NDC, 2 package rows20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-784-01EA - Each68308-784462faae8-2883-4ab8-904e-aad7aa61654212024-01-04
68308-784-30EA - Each68308-784a238822f-acae-4f2f-8696-c46354a4b72d12024-01-04

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 49 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
Ethyl AlcoholETHYL ALCOHOLUpLift Brands, LLC289d6e34-4d71-b24e-e063-6394a90ac26d2026-04-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Smart Care FRESH RAIN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.8f9e8021-877f-4888-94f9-9eee17fe2afb2026-04-10WarningsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
unii: 3K9958V90M
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care SUNSET GUAVA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.f9893cce-9350-4a5b-9fbb-081bf239b7972026-04-10WarningsExact identifier
unii: 3K9958V90M
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON WAVE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e2e78fc0-695f-452d-b126-359f33e7ba812026-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care OCEAN BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.99fb833d-61ce-45c7-9612-8774abb4dbb72026-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Sunset GuavaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f01fc3a-5b01-4b6b-e063-6294a90aefb42026-04-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f02adaa-1440-5778-e063-6294a90a344a2026-04-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Watermelon WaveALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f031f62-e56c-9063-e063-6394a90af9c12026-04-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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