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 18 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scentfull Hand Sanitizer Blue DriftwoodALCOHOLScent Theory Products LLC56572ebe-d624-6389-e063-6394a90a23b42026-07-11WarningsExact identifier
unii: 3K9958V90M
NutriLipid I.V. Fat EmulsionSOYBEAN OILB. Braun Medical Inc.193290b1-a0a1-4054-a22a-de5c9e7a8b732026-07-10Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Alcohol Cleansing WipeISOPROPYL ALCOHOLHubei Fanjian Medical Product Co.,Ltd1607fb06-826b-42bb-986e-0023a1b078f32026-07-10WarningsExact identifier
unii: ND2M416302
Purell Advanced SoothingALCOHOLGOJO Industries, LLC59b47629-8b4e-4084-8bc8-66c7e5599e9c2026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Gentle and Free FoamALCOHOLGOJO Industries, LLC70b13f86-4d1a-4221-b09d-7438163fe9b52026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance Free FoamALCOHOLGOJO Industries, LLC63c26f36-4bae-4cce-bacb-d0da66b228f72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Fresh SqueezeALCOHOLAmerican Exchange Group6a668197-1fa8-4c07-a520-20e194df39c52026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Paradise PleaseALCOHOLAmerican Exchange Group6d75c795-ff84-4775-8f7d-a2416acf845e2026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Hinoki HourALCOHOLAmerican Exchange Group303866ab-8b9f-4e74-8408-62e57bb731d72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Pineapple PopALCOHOLAmerican Exchange Group20aa290f-39e4-4bc9-9128-d6268d8d74d02026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Vanilla DaydreamALCOHOLAmerican Exchange Groupa188f0ef-75fa-4ace-8712-7ce592ae19572026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Clean GirlALCOHOLAmerican Exchange Groupf5588dff-3299-47c5-a570-94c346b6b2e92026-07-10WarningsExact identifier
unii: 3K9958V90M
Smart Care CHAMPAGNE TOAST 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios, Inc.1bd51131-b3df-4cf9-959b-45724484ffc62026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Biobased ContentALCOHOLGOJO Industries, LLC60584888-a800-4825-85b3-cf55ca7c045e2026-07-09WarningsExact identifier
unii: 3K9958V90M
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.28948c32-a598-4bb5-bdb5-efbd87214d982026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
unii: 3K9958V90M
ATTITUDE Little Leaves Hand Sanitizer Watermelon and CoconutETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d21713-f279-489c-e063-6394a90a67792026-07-08WarningsExact identifier
unii: 3K9958V90M
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd561af7a3-25a5-1384-e063-6394a90abb592026-07-08WarningsExact identifier
unii: 3K9958V90M
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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