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 73 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer with AloeALCOHOLUpLift Brands, LLC3b4d4901-cf7d-4048-8a24-cfb00fd8b1082026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
unii: 3K9958V90M
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIb63d9c12-8471-4db5-998b-ab46184495372026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIccf505f6-2b34-4a18-af07-92ed505644ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUline8ed759a2-fb0e-474e-8245-ddb798e542ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUline3bc9cfa2-2b1f-4892-93ff-cffa9f5878042026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUlinefdda41fa-d847-4cee-a070-91f0600b0fc82026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel The Upside DownALCOHOLBath & Body Works, Inc.29a539bb-42e7-dc73-e063-6394a90a5fe92026-02-17WarningsExact identifier
unii: 3K9958V90M
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.38d661c8-6f48-f58c-e063-6294a90ae8c12026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.38951f0d-0ec4-2406-e063-6394a90a9fe32026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38d656e3-5f8f-9874-e063-6394a90a8ea52026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus MintALCOHOLBath & Body Works, Inc.38d65eae-f1af-f342-e063-6294a90af7fe2026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer OCEAN BREEZE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2cf4bc63-6157-4c4f-bb52-aa685f8d4aee2026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO15a5272c-0abc-47e1-be21-91a601ead3082026-02-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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