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 19 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
unii: 3K9958V90M
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
unii: 3K9958V90M
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
ATTITUDE Super Leaves Hand Sanitizer Lemon LeavesETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d3c8c0-74d5-f49d-e063-6394a90a48152026-07-07WarningsExact identifier
unii: 3K9958V90M
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb487f98e-63b1-40d9-bc8b-524b4be3f86c2026-07-06WarningsExact identifier
unii: 3K9958V90M
Beach In A Bottle Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC556fa4b6-c1af-bc36-e063-6394a90a7f312026-07-06WarningsExact identifier
unii: 3K9958V90M
Sugarcoat Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5570284d-0872-1fee-e063-6294a90a9b652026-07-06WarningsExact identifier
unii: 3K9958V90M
Whipped Creme Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5570977b-6085-98d9-e063-6394a90aa1742026-07-06WarningsExact identifier
unii: 3K9958V90M
Santal Suede Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55712a8b-e633-2427-e063-6294a90a7c5a2026-07-06WarningsExact identifier
unii: 3K9958V90M
Sea Salt Bergamot Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55737186-41b1-b563-e063-6294a90ab8e92026-07-06WarningsExact identifier
unii: 3K9958V90M
Bourbon Vanilla Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55744cc5-5ef6-f2a1-e063-6394a90a3e6d2026-07-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands LLC044361fe-1e16-4fea-9094-a2d88c890d9c2026-07-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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