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 65 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Disney Princess MoanaALCOHOLBath & Body Works, Inc.38e22134-9661-bd86-e063-6294a90a6ae92026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Disney Princess BelleALCOHOLBath & Body Works, Inc.38e2212f-88d6-c792-e063-6394a90ae4922026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Disney Princess ArielALCOHOLBath & Body Works, Inc.38e2113f-2fce-90f7-e063-6394a90a754c2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Sweater WeatherALCOHOLBath & Body Works, Inc.4629294b-c756-6477-e063-6294a90a3d5d2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Disney Villains MaleficentALCOHOLBath & Body Works, Inc.45c39e1e-e48c-a285-e063-6294a90ac2c72026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel In The StarsALCOHOLBath & Body Works, Inc.45c4cd42-cdde-4e07-e063-6394a90a2a0f2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry SnowflakesALCOHOLBath & Body Works, Inc.46135c55-58fb-fe01-e063-6394a90ac4152026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin Pecan WafflesALCOHOLBath & Body Works, Inc.45c6b183-8dce-8120-e063-6394a90abdc92026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweater WeatherALCOHOLBath & Body Works, Inc.45c7071a-7a05-7ba1-e063-6294a90af89e2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla Bean NoelALCOHOLBath & Body Works, Inc.45c75b3d-c267-203f-e063-6394a90ae7b42026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Moonlit GoddessALCOHOLBath & Body Works, Inc.45c889cd-c377-d8c9-e063-6294a90a74b12026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.46136f12-b335-98c2-e063-6294a90a00af2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.4604db79-ddbe-c83d-e063-6394a90aadd82026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Honey WildflowerALCOHOLBath & Body Works, Inc.46153052-5e6e-b8d3-e063-6294a90a60fc2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel FreshwaterALCOHOLBath & Body Works, Inc.4613a872-0967-c800-e063-6394a90a22d02026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Bubble GumALCOHOLBath & Body Works, Inc.4614de38-80f8-26db-e063-6294a90ab4f82026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Winterberry IceALCOHOLBath & Body Works, Inc.46138a35-e974-a8bb-e063-6394a90a5b542026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel AdrenalineALCOHOLBath & Body Works, Inc.4613bfd7-77ff-e237-e063-6394a90ad3d62026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fiji White SandsALCOHOLBath & Body Works, Inc.461420e0-a5b1-81df-e063-6394a90a94ec2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.4613ce33-6881-e7c8-e063-6394a90a40902026-03-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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