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 213 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-BacterialHandSpray Twisted PeppermintALCOHOLBath & Body Works, Inc.29a4ff29-e2ee-526c-e063-6294a90ad01b2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink ChiffonALCOHOLBath & Body Works, Inc.29a539bb-42dd-dc73-e063-6394a90a5fe92024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White PumpkinALCOHOLBath & Body Works, Inc.29a536a0-3fb9-c35f-e063-6394a90ae1e32024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Together WeatherALCOHOLBath & Body Works, Inc.29a534f2-46cd-ea47-e063-6394a90a13192024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Rose Water and IvyALCOHOLBath & Body Works, Inc.29a539bb-42e2-dc73-e063-6394a90a5fe92024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla RomanceALCOHOLBath & Body Works, Inc.29a540fd-60b5-eb1e-e063-6394a90a27f72024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel FlannelALCOHOLBath & Body Works, Inc.29a54361-e108-20d7-e063-6294a90a117a2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Frozen LakeALCOHOLBath & Body Works, Inc.29a536d5-6abb-c0ef-e063-6394a90a15bb2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Marshmallow Pumpkin LatteALCOHOLBath & Body Works, Inc.29a5342a-e6dc-ea55-e063-6394a90a11e82024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin AppleALCOHOLBath & Body Works, Inc.29a536d5-6abf-c0ef-e063-6394a90a15bb2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.29a54361-e107-20d7-e063-6294a90a117a2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin CupcakeALCOHOLBath & Body Works, Inc.29a53c91-0bda-f572-e063-6294a90ae8952024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweater WeatherALCOHOLBath & Body Works, Inc.29a540fd-60b7-eb1e-e063-6394a90a27f72024-12-19WarningsExact identifier
unii: 3K9958V90M
Alcohol Antiseptic 70% Topical SolutionALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incaa95e99f-5c17-c394-e053-2995a90a6bf92024-12-19WarningsExact identifier
unii: 3K9958V90M
Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b4c26-469b-72ec-e053-2a95a90a05102024-12-19WarningsExact identifier
unii: 3K9958V90M
germstarONE unscentedETHYL ALCOHOLSoaptronic, LLCa6a798bd-09cb-1853-e053-2995a90a27f92024-12-19WarningsExact identifier
unii: 3K9958V90M
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
EXTENDED CARE Foaming Hand SanitizerALCOHOLTRIPLE A SUPPLIES, INC.f244f9c0-82c6-42a8-b0a8-63af546ed26f2024-12-19WarningsExact identifier
unii: 3K9958V90M
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
unii: 3K9958V90M
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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