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 74 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AURA LANE HAND SANITIZER Neroli Flower ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1cd1c0ee-1849-4003-a128-323d1b06aa402026-02-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip pancake scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO105d2927-59e1-46fb-ad48-ea45ed3051e82026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer MANDARIN ORANGE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO20a8d48d-aa4b-4904-84e9-54be5ddb43a02026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9eece9a7-3340-47ea-98aa-152d285e4c012026-02-16WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SWEET CHERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO990a5e7b-8fe4-4681-99eb-76445f9436a72026-02-16WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLC490a3484-04d7-4a90-b203-71971a869e8d2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLCe1bd99f5-8a96-442a-8c70-367df96c5cf02026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLVeritiv Operating Company3b8a41b3-54c5-f5c0-e063-6394a90a9fac2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLValu Merchandisers Company722abec8-5a05-4e6d-a7ea-da9d1009e8592026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLValu Merchandisers Companye8b82c44-cbe0-42b2-b920-fed8da8f79eb2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO65702a16-5a66-412a-b288-4d64488c1c422026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CHERRY BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCObabf61f9-f8e0-4423-bd53-9e0317b949962026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer WILD WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc9de44d4-50fa-460f-a443-b241e025db1e2026-02-16WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer VANILLA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe69b4735-fd8e-498f-86d2-b4fcb0aa57e52026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer ISLAND COCONUT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOa42fcba5-04fc-438f-ab5f-ea13f156689a2026-02-16WarningsExact identifier
unii: 3K9958V90M
SaniiSwabETHYL ALCOHOL 62%PolleyMed LLC3b06f3a4-de7f-0d16-e063-6394a90af0dc2026-02-14WarningsExact identifier
unii: 3K9958V90M
hand sanitizer strawberry matcha scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc41a3736-ce58-497c-aeba-2830cbd8a93b2026-02-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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