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 67 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
unii: ND2M416302
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Starfruit SangriaALCOHOLBath & Body Works, Inc.387caf6b-fda0-a63f-e063-6294a90a041a2026-03-03WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
AlcoholALCOHOLOld East Main Co.31a38e0e-41de-4638-9e86-df1923b64d522026-03-02Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and VanillaALCOHOLBath & Body Works, Inc.29a37aad-c6d3-b174-e063-6394a90abc3e2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and VanillaALCOHOLBath & Body Works, Inc.38d5a11f-d0cb-30eb-e063-6394a90a6a492026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.2b0f3ca1-0a68-08a6-e063-6294a90a9df22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.38e1c1d6-6511-4066-e063-6294a90ad3f42026-03-02WarningsExact identifier
unii: 3K9958V90M
Ethyl AlcoholETHYL ALCOHOLOld East Main Co.479d5880-1e7e-481e-98df-dd98324d6ab82026-03-02Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Anti-BacterialHandSpray White T ShirtALCOHOLBath & Body Works, Inc.29a38d22-0685-37af-e063-6294a90a31e62026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Passionfruit and Banana FlowerALCOHOLBath & Body Works, Inc.38d5d6c2-8ceb-40b7-e063-6394a90a2a8f2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray A Thousand WishesALCOHOLBath & Body Works, Inc.29a3aac8-2083-3ece-e063-6394a90ab4402026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray OceanALCOHOLBath & Body Works, Inc.29a38d22-068a-37af-e063-6294a90a31e62026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Champagne ToastALCOHOLBath & Body Works, Inc.29a3aa8a-c697-a873-e063-6294a90a72c42026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Peach BelliniALCOHOLBath & Body Works, Inc.297e26d2-128e-0aa5-e063-6294a90a34dc2026-03-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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