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 27 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.55300198-e9bc-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.552ffc4e-aded-ff0e-e063-6294a90abdc02026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.552ff81f-28da-0f6e-e063-6394a90ab5832026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cotton Candy CobwebsALCOHOLBath & Body Works, Inc.5530026f-04cf-471f-e063-6294a90a165e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.552fe73b-38e1-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.55300198-e9be-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
serendipity3 Hand Sanitizer Vanilla Ice Cream ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO849d99f7-2890-42b4-84ab-99ef811641d52026-06-26WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER CHERRY BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1f613b11-9dbd-4beb-9211-9d1fa3b2d7d92026-06-25WarningsExact identifier
unii: 3K9958V90M
Lights Medium AlcoholISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.873e0c9d-e0aa-44bb-a1f4-4474584790232026-06-25WarningsExact identifier
unii: ND2M416302
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
SOUR LEMON HAND SANITIZER WHITE PEACH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOddb9bf98-f94c-4306-a8b4-c711e926b6322026-06-25WarningsExact identifier
unii: 3K9958V90M
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
serendipity3 HAND SANITIZER Vanilla Honey SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2720c07c-e457-4377-b098-31c61c62e0122026-06-25WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER VANILLA BEAN SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2291c8b2-2ea7-4e64-91ac-ced8f8b03f402026-06-25WarningsExact identifier
unii: 3K9958V90M
serendipity3 Hand Sanitizer Butter Croissant ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO91a99a2c-0271-451b-b201-f369bca3da112026-06-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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