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 246 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Gingham GlowALCOHOLBath & Body Works, Inc.1aa32eca-8cf6-75cb-e063-6294a90ab72b2024-06-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.1ab87e4e-828e-75dd-e063-6294a90a81212024-06-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel First SightALCOHOLBath & Body Works, Inc.1a9e9349-9495-81a5-e063-6294a90a7b7b2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Flower ChildALCOHOLBath & Body Works, Inc.1a9ef8eb-325f-8c42-e063-6394a90a1ecc2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Amalfi LemonALCOHOLBath & Body Works, Inc.1a9f2550-319d-ea51-e063-6394a90ab0aa2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Cut LilacsALCOHOLBath & Body Works, Inc.1a9f4c77-1afb-35f2-e063-6394a90a82b92024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.1a9f6a23-1429-573d-e063-6394a90a0ea42024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel GinghamALCOHOLBath & Body Works, Inc.1aa2967a-d978-d294-e063-6294a90a25122024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Danbury ShortbreadALCOHOLBath & Body Works, Inc.1a8e81c0-c97d-100c-e063-6394a90ab2072024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Diamond Of The SeasonALCOHOLBath & Body Works, Inc.1a8e710e-521f-2d66-e063-6394a90a80de2024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Dressed In WhiteALCOHOLBath & Body Works, Inc.1a8eaa81-c110-69f1-e063-6394a90ab2642024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ebd8c-f7c6-9bf8-e063-6394a90ad8a82024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ee169-fec2-d98a-e063-6294a90a19792024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.1a8f680b-ab3f-a550-e063-6394a90ac9512024-06-10WarningsExact identifier
unii: 3K9958V90M
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
unii: ND2M416302
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
unii: 3K9958V90M
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
unii: 15FIX9V2JP
b pure Hydrating Hand Sanitizer Salted Caramel ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38e171-e2fb-206c-e063-6294a90ac6382024-06-06WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Caramel Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38d19b-7c00-1c2b-e063-6394a90a4caa2024-06-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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