FDA.reportPublic FDA data

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 69 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Afternoon Apple PickingALCOHOLBath & Body Works, Inc.369ac581-c59b-4eb5-e063-6394a90aec7a2026-03-02WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
unii: ND2M416302
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
unii: ND2M416302
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
unii: 3K9958V90M
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hand SanitizerETHYL ALCOHOLThe Kroger Co.9f95d956-25db-4ffa-86cc-a160677124b82026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLThe Kroger Co.a848de11-0438-400b-b363-df595692685a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLThe Kroger Co.163b479b-aa0f-4174-8dfb-ac33bd07752a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Ethyl alcoholETHYL ALCOHOLWalmart Inc.f7d9bb83-0b80-458b-9554-8adbe51473e42026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
Hand SanitizerALCOHOLWalmart Inc.2112ba04-1584-46dd-9a7b-2dfd27e501b72026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWalmart Inc.c05bcb17-f1f6-4e3a-b90a-5d003ce5215b2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Dial Professional Gel SanitizerDIAL PROFESSIONAL GEL HAND SANITIZERHenkel Corporation2862ab27-b5e7-8bdb-e063-6394a90abf802026-02-27WarningsExact identifier
unii: 3K9958V90M
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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